Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ongoing, recruiting
Participants planned
727
Countries
18
Sites
117
Refractory Focal Onset Epilepsy
To evaluate the safety and tolerability of BHV-7000
Key facts
- Sponsor
- Biohaven Therapeutics Ltd.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Trial duration
- 18 Dec 2024 → ongoing
- Decision date (initial)
- 2024-10-14
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Biohaven Therapeutics, Ltd.
External identifiers
- EU CT number
- 2023-508813-18-00
- ClinicalTrials.gov
- NCT06443463
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Others, Efficacy, Safety
To evaluate the safety and tolerability of BHV-7000
Conditions and MedDRA coding
Refractory Focal Onset Epilepsy
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10065337 | Focal epilepsy | 10029205 |
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Safety and tolerability of BHV-7000 assessment phase Eligible subjects who completed the DBP of the BHV7000-302 study will be initially assigned BHV-7000 50 mg dose at the baseline visit.
Eligible subjects who completed the DBP of the BHV7000-303 study will be initially assigned BHV-7000 75 mg dose at the baseline visit
|
2 | None | BHV-7000 50mg: 50mg dose BHV-7000 75mg: 75mg dose |
Regulatory references
- Scientific advice from competent authorities
- European Medicines Agency, Food And Drug Administration
- Plan to share IPD
- No
| EU CT number | Title | Sponsor |
|---|---|---|
| 2023-508811-21-00 | A Phase 2/3 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Efficacy, Safety and Tolerability of BHV-7000 in Subjects with Refractory Focal Onset Epilepsy | Biohaven Therapeutics Ltd. |
| 2023-508812-45-00 | A Phase 2/3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of BHV-7000 as Adjunctive Therapy in Subjects with Idiopathic Generalized Epilepsy with Generalized Tonic-clonic Seizures, with Open-label Extension | Biohaven Therapeutics Ltd. |
| 2023-508539-30-00 | A Phase 2/3 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Efficacy, Safety and Tolerability of BHV-7000 in Subjects with Refractory Focal Onset Epilepsy | Biohaven Therapeutics Ltd. |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 2
- 1. Subjects who completed the double-blind phase (DBP) of prior parent study, BHV7000-302 or BHV7000-303.
- 2. Females of childbearing potential (FOCBP) must have a negative urine pregnancy test at the Baseline/Day 0 visit.
Exclusion criteria 2
- 1. Any condition, such as an ongoing AE with/without sequalae, or is poorly tolerating IP in the DBP of the parent study, that would interfere with the subject’s ability to comply with study instructions, place the subject at unacceptable risk, and/or confound the interpretation of safety or efficacy data from the study, as judged by the Investigator.
- 2. Any medical condition, based on the judgement of the Investigator, that would confound the ability to adequately assess safety and efficacy outcome measures.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Safety is assessed by the number of unique subjects with deaths, SAE’s, AE’s leading to discontinuation, moderate and severe AEs and grade 3 and 4 laboratory abnormalities
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
PRD10918476 · Product
- Active substance
- BHV-7000
- Pharmaceutical form
- PROLONGED-RELEASE TABLET
- Route of administration
- ORAL
- Max daily dose
- 75 mg milligram(s)
- Max total dose
- 27300 mg milligram(s)
- Max treatment duration
- 52 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- BIOHAVEN THERAPEUTICS LTD
- Paediatric formulation
- No
- Orphan designation
- No
PRD10918475 · Product
- Active substance
- BHV-7000
- Pharmaceutical form
- PROLONGED-RELEASE TABLET
- Route of administration
- ORAL
- Max daily dose
- 75 mg milligram(s)
- Max total dose
- 27300 mg milligram(s)
- Max treatment duration
- 52 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- BIOHAVEN THERAPEUTICS LTD
- Paediatric formulation
- No
- Orphan designation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Biohaven Therapeutics Ltd.
- Sponsor organisation
- Biohaven Therapeutics Ltd.
- Address
- 215 Church Street
- City
- New Haven
- Postcode
- 06510-1803
- Country
- United States
Scientific contact point
- Organisation
- Biohaven Therapeutics Ltd.
- Contact name
- Research and Development Medical Director
Public contact point
- Organisation
- Biohaven Therapeutics Ltd.
- Contact name
- Chief Operating Officer
Third parties 8
| Organisation | City, country | Duties |
|---|---|---|
| Medidata Solutions Inc. ORG-100016256
|
New York, United States | E-data capture |
| 4g Clinical LLC ORG-100042775
|
Wellesley, United States | Interactive response technologies (IRT) |
| PPD Global Ltd. ORG-100007531
|
Marousi, Greece | On site monitoring, Code 5 |
| PPD Global Central Labs ORG-100046496
|
Zaventem, Belgium | Laboratory analysis |
| Eresearchtechnology Inc. ORG-100013039
|
Philadelphia, United States | Other |
| PPD Development LP ORG-100011560
|
Wilmington, United States | On site monitoring, Code 11, Code 12, Code 13, Code 14, Code 2, Code 5, Data management, Code 8, Code 9 |
| WCG Clinical Inc. ORG-100040730
|
Plymouth Meeting, United States | Other |
| Scout Clinical ORG-100042228
|
Dallas, United States | Other |
Locations
18 EU/EEA countries · 117 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ongoing, recruiting | 5 | 4 |
| Belgium | Ongoing, recruiting | 20 | 5 |
| Croatia | Authorised, recruiting | 20 | 4 |
| Czechia | Ongoing, recruiting | 18 | 2 |
| Denmark | Ongoing, recruiting | 28 | 3 |
| Finland | Ongoing, recruiting | 8 | 3 |
| France | Ongoing, recruiting | 24 | 9 |
| Germany | Ongoing, recruiting | 54 | 14 |
| Greece | Ongoing, recruiting | 18 | 6 |
| Hungary | Ongoing, recruiting | 20 | 4 |
| Italy | Ongoing, recruiting | 48 | 17 |
| Netherlands | Ongoing, recruiting | 8 | 3 |
| Poland | Ongoing, recruiting | 82 | 15 |
| Portugal | Ongoing, recruiting | 18 | 6 |
| Romania | Ongoing, recruiting | 12 | 2 |
| Slovakia | Ongoing, recruiting | 6 | 2 |
| Slovenia | Ongoing, recruiting | 8 | 1 |
| Spain | Ongoing, recruiting | 51 | 17 |
| Rest of world
Chile, United Kingdom, United States, South Africa, Switzerland, Argentina, Mexico, Australia
|
— | 279 | — |
Investigational sites
Noe LGA Gesundheit Region Mitte GmbH
Klinische Abteilung für Neurologie, Dunant-Platz 1, 3100, St. Poelten
Medical University Of Vienna
Universitätsklinik für Neurologie, Waehringer Guertel 18-20, Alsergrund, Vienna
Gemeinnuetzige Salzburger Landeskliniken Betriebsgesellschaft mbH
n/a, Ignaz-Harrer-Strasse 79, 5020, Salzburg
Johannes Kepler University Linz
Universitätsklinik für Neurologie, Wagner Jauregg Weg 15, 4020, Linz
Hopital Erasme
Neurology, Lennikse Baan 808, 1070, Anderlecht
Universitair Ziekenhuis Gent
Neurology, Corneel Heymanslaan 10, 9000, Gent
Antwerp University Hospital
Neurology, Drie Eikenstraat 655, 2650, Edegem
Cliniques Universitaires Saint-Luc
Neurology, Hippokrateslaan 10, Batiment 54, Sint-Lambrechts-Woluwe
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur
Neurology, Avenue Docteur Gaston Therasse 1, 5530, Yvoir
University Hospital Sveti Duh
Neurology clinic, Sveti Duh 64, 10000, Zagreb
Klinicki bolnicki centar Sestre milosrdnice
Paediatric clinic, Vinogradska Cesta 29, Zagreb, Grad Zagreb
University Hospital Centre Zagreb
Neurology, Ulica Mije Kispatica 12, 10000, Zagreb
Clinical Hospital Centre Rijeka
Neurology and Child Psychiatry, Kresimirova 42, 51000, Rijeka
Fakultni Nemocnice U Sv Anny V Brne
I. neurologická klinika, Pekarska 53, Stare Brno, Brno-Stred
Fakultni Nemocnice V Motole
Neurologická klinika 2.LF UK a FN Motol, V Uvalu 84/1, Motol, Prague
Odense University Hospital
Neurologisk Afdeling N,, J B Winsloews Vej 4, 5000, Odense C
Filadelfia
Danish Epilepsy Center, Adult Department, Kolonivej 2A, Kolonivej 1, 4293, Dianalund
Region Midtjylland
DA - Århus universitetshospital, Department of Neurology, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N
Pohjois-Savon hyvinvointialue
Kuopio Epilepsy Center, Neurocenter, Puijonlaaksontie 2, P. O. Box 1711, Kuopio
HUS-Yhtymae
Department of Neurology, Haartmaninkatu 4, 00290, Helsinki
Tampere University Hospital
Outpatient Clinic of Neurology, Elamanaukio 2, 33520, Tampere
Hospices Civils De Lyon
Département de Neurologie fonctionnelle et d’Epileptologie, 59 Boulevard Pinel, 69500, Bron
Centre Hospitalier Universitaire De Rennes
Service de Neurologie – Service d’Epileptologie Vincent Van Gogh, 2 Rue Henri Le Guilloux, 35000, Rennes
Centre Hospitalier Universitaire De Montpellier
Département Neurologie Exploratoire et Epileptologie, 80 Avenue Augustin Fliche, 34295, Montpellier Cedex 5
Centre Hospitalier Regional Universitaire De Tours
Service de Neurologie et de Neurophysiologie Clinique, 2 Boulevard Tonnelle, 37000, Tours
Centre Hospitalier Universitaire De Dijon
Département de Neurophysiologie Clinique et Centre SLA, 14 Rue Paul Gaffarel, 21000, Dijon
Centre Hospitalier Universitaire De Toulouse
Département d’Explorations Neurophysiologiques, 1 Place Du Docteur Joseph Baylac, 31300, Toulouse
Les Hopitaux Universitaires De Strasbourg
Hôpital HAUTEPIERRE - Département de Neurologie, 1 Place De L Hopital, Cs 80426, Strasbourg Cedex
Centre Hospitalier Universitaire De Lille
Département de Neurophysiologies Clinique, Rue Emile Laine, 59037, Lille Cedex
CHRU De Nancy
Service de Neurologie, Co N°34, 29 Avenue Du Mal De Lattre De Tassigny, Nancy Cedex
Gesellschaft Fuer Epilepsieforschung
Krankenhaus Mara – Epilepsiezentrum Bethel, Maraweg 21, Gadderbaum, Bielefeld
Klinikum der Universitaet Muenchen AöR
Neurologische Klinik und Poliklinik, Marchioninistrasse 15, Hadern, Munich
Universitaetsklinikum Ulm AöR
Klinik für Neurologie, Oberer Eselsberg 45, Eselsberg, Ulm
Vivantes Netzwerk fuer Gesundheit GmbH
Klinik für Neurologie - Stroke Unit - Zentrum für Epilepsie, Am Nordgraben 2/1, Wittenau, Berlin
Philipps-Universitaet Marburg
Klinik für Neurologie, Baldingerstrasse, 35043, Marburg
ZfP Südwürttemberg
Klinik für Neurologie und Epileptologie, Weingartshofer Straße 2, 88214, Ravensburg
Diakonie Kork
Epilepsiezentrum, Landstrasse 1, Kork, Kehl
Klinikum Osnabrueck GmbH
Klinik für Neurologie und neurologische Frührehabilitation, Am Finkenhuegel 1-3, Westerberg, Osnabrueck
Goethe University Frankfurt
Klinik für Neurologie, Haus 23D, Theodor-Stern-Kai 7, 60590, Frankfurt Am Main
Medical Center - University Of Freiburg
Epilepsiezentrum im Neurozentrum, Breisacher Strasse 64, Stuehlinger, Freiburg Im Breisgau
Universitaetsklinikum Erlangen AöR
Neurologische Klinik Epilepsiezentrum, Schwabachanlage 6, Innenstadt, Erlangen
Universitaetsklinikum Bonn AöR
Klinik und Poliklinik für Epileptologie, Venusberg-Campus 1, Venusberg, Bonn
Universitaetsklinikum Leipzig AöR
Klinik und Poliklinik für Neurologie, Liebigstrasse 20, Zentrum-Suedost, Leipzig
Epilepsiezentrum Kleinwachau gGmbH
Fachklinik für Neurologie, Wachauer Strasse 30, Liegau-Augustusbad, Radeberg
University General Hospital Of Ioannina
Neurology Clinic, Niarchou Stavrou Avenue, 455 00, Ioannina
University General Hospital Of Alexandroupoli
Department of Neurology, 6th Km Alex Polis Makris, Dragana, Alexandroupoli
Geniko Nosokomeio Thessalonikis George Papanikolaou
3rd Department of Neurology Aristotle University of Thessaloniki, Exochi, 570 10, Thessaloniki
University General Hospital Of Thessaloniki Ahepa
1st Department of Neurology, 1st St Kiriakidis Str, 546 36, Thessaloniki
University General Hospital Of Thessaloniki Ahepa
2nd Department of Neurology, 1st St Kiriakidis Str, 546 36, Thessaloniki
University General Hospital Attikon General Hospital Of West Attica H Agia Varvara
2nd Neurology Clinic, NKUA, Rimini 1, 124 61, Chaidari
University Of Pecs
Neurológiai Klinika, Ret Utca 2, 7623, Pecs
University Of Debrecen
DE Klinikai Központ (DEKK) Neurológiai Klinika, Bartok Bela Ut 2-26, 4031, Debrecen
Budapesti Bajcsy-Zsilinszky Korhaz Es Rendelointezet
Neurológia Osztály, Maglodi Ut 89-91, Kerulet, Budapest
Semmelweis University
Idegsebészeti és Neurointervenciós Klinikája, Amerikai Ut 57, 1145, Budapest XIV
IRCCS Foundation Istituto Neurologico Carlo Besta
SC Neurologia 7 – Epilettologia Clinica e Sperimentale, Via Giovanni Celoria 11, 20133, Milan
Ospedale Pediatrico Bambino Gesu
U.O.C. Neurologia dell'epilessia e disturbi del movimento, Piazza Di Sant'onofrio 4, 00165, Rome
Azienda Socio Sanitaria Territoriale Santi Paolo E Carlo
Centro Regionale Epilessia e medicina del sonno, Via Antonio Di Rudini' 8, 20142, Milan
Istituto Neurologico Mediterraneo Neuromed S.p.A.
Centro per lo studio e la cura dell'epilessia, Via Atinense N. 18, 86077, Pozzilli
Azienda Ospedaliero Universitaria Renato Dulbecco
U.O.C. Neurologia, Viale Europa, 88100, Catanzaro
Azienda Unita Sanitaria Locale Di Bologna
Programma Epilessia, Via Altura 3, 40139, Bologna
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
U.O.C. Neuropsichiatria Pediatrica, Largo Francesco Vito 1, 00168, Rome
Ospedale San Raffaele S.r.l.
U.O. Neurologia, Via Olgettina 60, 20132, Milan
IRCCS Istituto Giannina Gaslini
U.O.C. Neurologia Pediatrica e Malattie Muscolari, Via Gerolamo Gaslini 5, 16147, Genoa
Universita' Degli Studi G. D'Annunzio Di Chieti
Department of Neuroscience, Imaging and Clinical Sciences, Via Luigi Polacchi 11, 66100, Chieti Scalo
Azienda Ospedaliero Universitaria Delle Marche
Dipartimento di Medicina Sperimentale e Clinica, Via Conca 71, 60126, Ancona
Azienda Ospedaliera Di Rilievo Nazionale Antonio Cardarelli
U.O.C. di Neurofisiopatologia, Via Antonio Cardarelli 9, 80131, Naples
Azienda Ospedaliera Universitaria Integrata Verona
S.C. Neuropsichiatria Infantile, Piazzale Aristide Stefani 1, 37126, Verona
Azienda Ospedaliera Policlinico Universitario Tor Vergata
Neurology Unit, Viale Oxford 81, 00133, Rome
Azienda Ospedaliero Universitaria Di Modena
Neurology Unit, Via Pietro Giardini 1355, 41126, Modena
Azienda Ospedaliera Universitaria Meyer IRCCS
Neuroscience Excellence Center, Viale Gaetano Pieraccini 24, 50139, Florence
Fondazione Istituto Neurologico Nazionale Casimiro Mondino
SC Neuropsichiatria Infantile, Via Casimiro Mondino 2, 27100, Pavia
Kempenhaeghe
Neurology, Sterkselseweg 65, 5591 VE, Heeze
Epilepsie Instellingen Nederland Stichting
Neurology, Dokter Denekampweg 20, 8025 BV, Zwolle
Epilepsie Instellingen Nederland Stichting
Neurology, Achterweg 5, 2103 SW, Heemstede
Clinical Best Solutions Sp. z o.o. S.K.
n/a, Aleja Jozefa Pilsudskiego 11, 20-011, Lublin
Santa Sp. z o.o.
n/a, Pilota Stanislawa Wigury 19, 90-302, Lodz
Neurosphera Sp. z o.o.
N/A, Ul. Taneczna 30, 02-829, Warsaw
Novo-Med Zielinski I Wspolnicy Sp. j.
NIEPUBLICZNY ZAKŁAD OPIEKI ZDROWOTNEJ NOVO-MED, Ul. Brynowska 44, 40-584, Katowice
Copernicus Podmiot Leczniczy Sp. z o.o.
n/a, Ul. Nowe Ogrody 1/6, 80-803, Gdansk
Synexus Polska Sp. z o.o.
Oddział w Poznaniu, Ul. Glogowska 31/33, 60-702, Poznan
Mtz Clinical Research Powered By Pratia
n/a, Ul. Gładka 22, 02-172, Warsaw
Pratia S.A.
n/a, Ul. Pana Tadeusza 2, 30-727, Cracow
NZOZ IGNIS dr med. Alicja Łobinska
n/a, ul. Stanislawa Skarzynskiego 12A, 21-040, Świdnik
Twoja Przychodnia Nowosolskie Centrum Medyczne Sp. z o.o.
n/a, Ul. Glowackiego 8d/2, 67-100, Nowa Sol
Centrum Badan Klinicznych Pi-House Sp. z o.o.
n/a, Ul. Na Zaspe 3, 80-546, Gdansk
Vistamed & Vertigo Sp. z o.o.
n/a, Ul Raclawicka 105 1b, 53-149, Wroclaw
LANDA Specjalistyczne Gabinety Lekarskie
N/A, ul. Zacisze 4/1, 31-156, Kraków
Instytut Psychiatrii I Neurologii
II Klinika Neurologiczna, Sobieskiego 9 Street, 02-957, Warsaw
Premium Clinic Wrocław CM
n/a, ul. Podwale 83 lok. 10.2, 50-414, Wrocław
Unidade Local De Saude De Coimbra E.P.E.
Neurology, Praceta Professor Mota Pinto, 3004-561, Coimbra
Unidade Local De Saude De Entre O Douro E Vouga E.P.E.
Serviço de Neurologia, Rua Doutor Candido Pinho, 4520-211, Santa Maria Da Feira
Hospital Da Luz Torres De Lisboa
Neurology Unit, Bldgs B D E And F, Rua Tomas Da Fonseca, Lisbon
CCAB Centro Clinico Academico Braga Associacao
Neurology Unit, Lugar De Sete Fontes S Victor, 4710-243, Braga
Unidade Local De Saude De Lisboa Ocidental E.P.E.
Neurology, Rua Da Junqueira 126, 1349-019, Lisbon
Hospital Pedro Hispano
Neurology Unit, Rua Doutor Eduardo Torres 1, 4450-113, Matosinhos
Spitalul Clinic Judetean De Urgenta Targu Mures
Sectia Clinica Neurologie II, Strada Marinescu Gheorghe 50, 540136, Targu Mures
Spitalul Universitar De Urgenta Bucuresti
Neurology Department, Splaiul Independentei 169, 050098, Bucharest
In Medic s.r.o.
N/A, Sv. Jakuba 8, 085 01, Bardejov
Penta Hospitals SK a.s.
Všeobecná nemocnica Rimavská Sobota, Srobarova 1, 979 01, Rimavska Sobota
Hospital Germans Trias I Pujol
Neurologia, Carretera Canyet 1a Planta, 08916, Badalona
Bellvitge University Hospital
Neurology, Carrer De La Feixa Llarga S/N, 08907, L'Hospitalet De Llobregat
Hospital Ruber Internacional
Neurology, Calle La Maso 38, 28035, Madrid
Hospital Universitario Regional De Malaga
Neurology, Avenida De Carlos De Haya S/N, 29010, Malaga
Hospital Universitario Clinico San Cecilio
Neurology, Avenida Del Conocimiento S/n, Poligono Industrial De Ciencias De La Salud, Granada
Hospital Universitario De Navarra
Neurology, Irunlarrea Kalea 3, 31008, Pamplona
Hospital Universitario Y Politecnico La Fe
Neurology, Avenida De Fernando Abril Martorell 106, 46026, Valencia
Hospital Universitario Virgen De Las Nieves
Neurology, Avenida De Las Fuerzas Armadas 2, 18014, Granada
Centro De Neurologia Avanzada S.L.P.
Neurology, Avenida Manuel Siurot 43a, 41013, Sevilla
Hospital Del Mar
Neurology, Passeig Maritim De La Barceloneta 25-29, 08003, Barcelona
Hospital Alvaro Cunqueiro
Neurology, Estrada Clara Campoamor No 341, 36312, Vigo
Hospital Universitari Vall D Hebron
Neurology, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Clinico Universitario De Valladolid
Neurology, Avenida Ramon Y Cajal 3, 47003, Valladolid
Hospital Vithas La Salud
Neurology, Avenida De Santa Maria De La Alhambra Sn, 18008, Granada
Hospital Universitario Fundacion Jimenez Diaz
Neurology, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Hospital Blua Sanitas Valdebebas
Neurology, Calle De Gustavo Perez Puig 66, 28055, Madrid
Fundacio Assistencial De Mutua De Terrassa Fpc
Neurology, Calle De San Antonio No 32, 08221, Terrassa
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Austria | 2025-04-24 | 2025-07-02 | |||
| Belgium | 2025-03-28 | 2025-04-24 | |||
| Croatia | 2025-07-02 | ||||
| Czechia | 2025-05-21 | 2025-06-17 | |||
| Denmark | 2025-02-18 | 2025-04-02 | |||
| Finland | 2025-06-16 | 2025-07-31 | |||
| France | 2025-06-11 | 2025-08-26 | |||
| Germany | 2025-04-29 | 2025-05-26 | |||
| Greece | 2025-09-03 | 2025-10-08 | |||
| Hungary | 2025-02-10 | 2025-03-25 | |||
| Italy | 2025-03-28 | 2025-05-14 | |||
| Netherlands | 2025-08-21 | 2025-09-30 | |||
| Poland | 2025-02-04 | 2025-03-13 | |||
| Portugal | 2025-02-24 | 2025-07-01 | |||
| Romania | 2025-10-14 | 2025-11-19 | |||
| Slovakia | 2025-12-15 | 2026-01-14 | |||
| Slovenia | 2025-03-20 | 2025-04-21 | |||
| Spain | 2024-12-18 | 2025-03-06 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 178 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Biohaven_BHV-7000-201_Protocol_2023-508813-18-00_GRC_Public | 1.3 |
| Protocol (for publication) | D1_Biohaven_BHV-7000-201_Protocol_2023-508813-18-00_Public | 1.3 |
| Protocol (for publication) | D4_Biohaven_BHV7000-201_Dosing Diaries_AUT_Public | 2.0 |
| Protocol (for publication) | D4_Biohaven_BHV7000-201_Dosing Diaries_CAT for ESP_Public | 2.0 |
| Protocol (for publication) | D4_Biohaven_BHV7000-201_Dosing Diaries_CZE_Public | 2.0 |
| Protocol (for publication) | D4_Biohaven_BHV7000-201_Dosing Diaries_DEU_Public | 2.0 |
| Protocol (for publication) | D4_Biohaven_BHV7000-201_Dosing Diaries_ENG_Public | 2.0 |
| Protocol (for publication) | D4_Biohaven_BHV7000-201_Dosing Diaries_ESP_Public | 2.0 |
| Protocol (for publication) | D4_Biohaven_BHV7000-201_Dosing Diaries_FRA for BEL_Public | 2.0 |
| Protocol (for publication) | D4_Biohaven_BHV7000-201_Dosing Diaries_FRA_Public | 2.0 |
| Protocol (for publication) | D4_Biohaven_BHV7000-201_Dosing Diaries_GRC_Public | 2.0 |
| Protocol (for publication) | D4_Biohaven_BHV7000-201_Dosing Diaries_HRV_Public | 2.0 |
| Protocol (for publication) | D4_Biohaven_BHV7000-201_Dosing Diaries_HUN_Public | 2.0 |
| Protocol (for publication) | D4_Biohaven_BHV7000-201_Dosing Diaries_ITA_Public | 2.0 |
| Protocol (for publication) | D4_Biohaven_BHV7000-201_Dosing Diaries_NLD for BEL_Public | 2.0 |
| Protocol (for publication) | D4_Biohaven_BHV7000-201_Dosing Diaries_POL_Public | 2.0 |
| Protocol (for publication) | D4_Biohaven_BHV7000-201_Dosing Diaries_POR_Public | 2.0 |
| Protocol (for publication) | D4_Biohaven_BHV7000-201_Dosing Diaries_ROU_Public | 2.0 |
| Protocol (for publication) | D4_Biohaven_BHV7000-201_Dosing Diaries_SVK_Public | 2.0 |
| Protocol (for publication) | D4_Biohaven_BHV7000-201_Dosing Diaries_SVN_Public | 2.0 |
| Protocol (for publication) | D4_Biohaven_BHV7000-201_Scales PFMs_AUT_Public | N/A |
| Protocol (for publication) | D4_Biohaven_BHV7000-201_Scales PFMs_CZE_Public | N/A |
| Protocol (for publication) | D4_Biohaven_BHV7000-201_Scales PFMs_DEU_Public | N/A |
| Protocol (for publication) | D4_Biohaven_BHV7000-201_Scales PFMs_ENG_Public | N/A |
| Protocol (for publication) | D4_Biohaven_BHV7000-201_Scales PFMs_ESP_Public | N/A |
| Protocol (for publication) | D4_Biohaven_BHV7000-201_Scales PFMs_FRA for BEL_Public | N/A |
| Protocol (for publication) | D4_Biohaven_BHV7000-201_Scales PFMs_FRA_Public | N/A |
| Protocol (for publication) | D4_Biohaven_BHV7000-201_Scales PFMs_GRC_Public | N/A |
| Protocol (for publication) | D4_Biohaven_BHV7000-201_Scales PFMs_HRV_Public | N/A |
| Protocol (for publication) | D4_Biohaven_BHV7000-201_Scales PFMs_HUN_Public | N/A |
| Protocol (for publication) | D4_Biohaven_BHV7000-201_Scales PFMs_ITA_Public | N/A |
| Protocol (for publication) | D4_Biohaven_BHV7000-201_Scales PFMs_NLD for BEL_Public | N/A |
| Protocol (for publication) | D4_Biohaven_BHV7000-201_Scales PFMs_POL_Public | N/A |
| Protocol (for publication) | D4_Biohaven_BHV7000-201_Scales PFMs_PRT_Public | N/A |
| Protocol (for publication) | D4_Biohaven_BHV7000-201_Scales PFMs_ROU_Public | N/A |
| Protocol (for publication) | D4_Biohaven_BHV7000-201_Scales PFMs_SVK_Public | N/A |
| Protocol (for publication) | D4_Biohaven_BHV7000-201_Scales PFMs_SVN_Public | N/A |
| Protocol (for publication) | D4_Biohaven_BHV7000-201_WCG eDiary PFMs_AT_Public | n/a |
| Protocol (for publication) | D4_Biohaven_BHV7000-201_WCG eDiary PFMs_CZ_Public | n/a |
| Protocol (for publication) | D4_Biohaven_BHV7000-201_WCG eDiary PFMs_DE_Public | n/a |
| Protocol (for publication) | D4_Biohaven_BHV7000-201_WCG eDiary PFMs_EN_Public | n/a |
| Protocol (for publication) | D4_Biohaven_BHV7000-201_WCG eDiary PFMs_ES_Public | n/a |
| Protocol (for publication) | D4_Biohaven_BHV7000-201_WCG eDiary PFMs_FR for BE_Public | n/a |
| Protocol (for publication) | D4_Biohaven_BHV7000-201_WCG eDiary PFMs_FR_Public | n/a |
| Protocol (for publication) | D4_Biohaven_BHV7000-201_WCG eDiary PFMs_GR_Public | N/A |
| Protocol (for publication) | D4_Biohaven_BHV7000-201_WCG eDiary PFMs_HR_Public | n/a |
| Protocol (for publication) | D4_Biohaven_BHV7000-201_WCG eDiary PFMs_HU_Public | n/a |
| Protocol (for publication) | D4_Biohaven_BHV7000-201_WCG eDiary PFMs_IT_Public | n/a |
| Protocol (for publication) | D4_Biohaven_BHV7000-201_WCG eDiary PFMs_NL for BE_Public | n/a |
| Protocol (for publication) | D4_Biohaven_BHV7000-201_WCG eDiary PFMs_PL_Public | n/a |
| Protocol (for publication) | D4_Biohaven_BHV7000-201_WCG eDiary PFMs_PT_Public | N/A |
| Protocol (for publication) | D4_Biohaven_BHV7000-201_WCG eDiary PFMs_RO_Public | N/A |
| Protocol (for publication) | D4_Biohaven_BHV7000-201_WCG eDiary PFMs_SI_Public | n/a |
| Protocol (for publication) | D4_Biohaven_BHV7000-201_WCG eDiary PFMs_SK_Public | N/A |
| Recruitment arrangements (for publication) | K1_BHV-7000-201_Recruitment Informed Consent Procedure_BE_Public | 2 |
| Recruitment arrangements (for publication) | K1_BHV-7000-201_Recruitment_Procedure_FRA_French_Public | 2.0 |
| Recruitment arrangements (for publication) | K1_BHV-7000-201_Recruitment-Arrangements_DNK_English_Public | 1.0 |
| Recruitment arrangements (for publication) | K1_BHV-7000-201_Recruitment-Informed-Consent-Procedure_HRV_English_Public | 2.0 |
| Recruitment arrangements (for publication) | K1_BHV7000-201_Recruitment and Informed consent procedure_CZE_English_Public | 1.0 |
| Recruitment arrangements (for publication) | K1_BHV7000-201_Recruitment arrangements_FIN_Finnish_Public | 2.0 |
| Recruitment arrangements (for publication) | K1_BHV7000-201_Recruitment_Arrangements_SLO_Public | 2.0 |
| Recruitment arrangements (for publication) | K1_BHV7000-201_Recruitment_Arrangements_SLO_TC_NotPublic | 2.0 |
| Recruitment arrangements (for publication) | K1_BHV7000-201_Recruitment_Informed_Consent_Procedure_AT_Public | 1.0 |
| Recruitment arrangements (for publication) | K1_BHV7000-201_Recruitment_Informed_Consent_Procedure_HU_Public | 2.0 |
| Recruitment arrangements (for publication) | K1_BHV7000-201_Recruitment-Arrangements_ES_Public | 2.0 |
| Recruitment arrangements (for publication) | K1_BHV7000-201_Recruitment-Arrangements_GRC_English_Public | 2.0 |
| Recruitment arrangements (for publication) | K1_BHV7000-201_Recruitment-Arrangements_IT_Public | 2.0 |
| Recruitment arrangements (for publication) | K1_BHV7000-201_Recruitment-Arrangements_NL_English_Public | n/a |
| Recruitment arrangements (for publication) | K1_BHV7000-201_Recruitment-Arrangements_PL_Polish_Public | 2.0 |
| Recruitment arrangements (for publication) | K1_BHV7000-201_Recruitment-Arrangements_PT_Public | 2.0 |
| Recruitment arrangements (for publication) | K1_BHV7000-201_Recruitment-Arrangements_ROU_Public | 2.0 |
| Recruitment arrangements (for publication) | K1_BHV7000-201_Recruitment-Arrangements_SK_Public | 2.0 |
| Recruitment arrangements (for publication) | K1_BHV7000-201_Recruitment-Arrangments_DE_Public | 2.0 |
| Recruitment arrangements (for publication) | K2_BHV7000-201_GP-Letter_IT_Italian_Public | 2.0 |
| Subject information and informed consent form (for publication) | L_BHV7000-201_List-of-submitted-patient-material_Public | n/a |
| Subject information and informed consent form (for publication) | L1_BHV7000-201_Caregiver_ICF_GRC_English_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_BHV7000-201_Caregiver_ICF_GRC_Greek_Public | 4.0 |
| Subject information and informed consent form (for publication) | L1_BHV7000-201_Caregiver-ICF_HRV_Croatian_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_BHV7000-201_GDPR-ICF_SK_Slovak_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_BHV7000-201_ICF_GDPR_CZE_Czech_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_BHV7000-201_ICF_Main_CZE_Czech_Public | 4.0 |
| Subject information and informed consent form (for publication) | L1_BHV7000-201_ICF_Pregnant Partner_CZE_Czech_Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_BHV7000-201_ICF-Main_DNK_Danish_Public | 4.0 |
| Subject information and informed consent form (for publication) | L1_BHV7000-201_ICF-PP_DNK_Danish_Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_BHV7000-201_Main ICF HUN Hungarian_Public | 4 |
| Subject information and informed consent form (for publication) | L1_BHV7000-201_Main ICF_FIN_Finnish_Public | 4.0 |
| Subject information and informed consent form (for publication) | L1_BHV7000-201_Main_ICF_ES_Spanish_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_BHV7000-201_Main_ICF_FRA_French_Public | 4.0 |
| Subject information and informed consent form (for publication) | L1_BHV7000-201_Main_ICF_IT_Italian_Public | 4.0 |
| Subject information and informed consent form (for publication) | L1_BHV7000-201_Main-ICF_BE_Dutch_Public | 4.0 |
| Subject information and informed consent form (for publication) | L1_BHV7000-201_Main-ICF_BE_English_Public | 4.0 |
| Subject information and informed consent form (for publication) | L1_BHV7000-201_Main-ICF_BE_French_Public | 4.0 |
| Subject information and informed consent form (for publication) | L1_BHV7000-201_Main-ICF_DE_German_Public | 4.0 |
| Subject information and informed consent form (for publication) | L1_BHV7000-201_Main-ICF_ES_Catalan_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_BHV7000-201_Main-ICF_GRC_English_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_BHV7000-201_Main-ICF_GRC_Greek_Public | 4.0 |
| Subject information and informed consent form (for publication) | L1_BHV7000-201_Main-ICF_HRV_Croatian_Public | 4.0 |
| Subject information and informed consent form (for publication) | L1_BHV7000-201_Main-ICF_PL_Polish_Public | 4.0 |
| Subject information and informed consent form (for publication) | L1_BHV7000-201_Main-ICF_PT_Portuguese_Public | 4.0 |
| Subject information and informed consent form (for publication) | L1_BHV7000-201_Main-ICF_Public | 4.0 |
| Subject information and informed consent form (for publication) | L1_BHV7000-201_Main-ICF_ROU_English_Public | 4.0 |
| Subject information and informed consent form (for publication) | L1_BHV7000-201_Main-ICF_ROU_Romanian_Public | 4.0 |
| Subject information and informed consent form (for publication) | L1_BHV7000-201_Main-ICF_SK_Slovak_Public | 4.0 |
| Subject information and informed consent form (for publication) | L1_BHV7000-201_Main-ICF_SLO_Slovenian_Public | 4.0 |
| Subject information and informed consent form (for publication) | L1_BHV7000-201_Optional-Use-Scout-Clinical-for-Caregiver_HRV_Croatian_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_BHV7000-201_Optional-Use-Scout-Clinical-for-Subject_HRV_Croatian_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_BHV7000-201_PP ICF_FIN_Finnish_Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_BHV7000-201_PP-ICF_AT_German_Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_BHV7000-201_PP-ICF_PL_Polish_Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_BHV7000-201_Pregnancy-and-Newborn-Data-Collection-ICF_PT_Portuguese_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_BHV7000-201_Pregnancy-FUP-and-Newborn-ICF_BE_Dutch_Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_BHV7000-201_Pregnancy-FUP-and-Newborn-ICF_BE_English_Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_BHV7000-201_Pregnancy-FUP-and-Newborn-ICF_BE_French_Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_BHV7000-201_Pregnancy-Newborn_ICF_GRC_English_Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_BHV7000-201_Pregnancy-Newborn_ICF_GRC_Greek_Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_BHV7000-201_Pregnant Partner ICF_HUN Hungarian_Public | 1.2 |
| Subject information and informed consent form (for publication) | L1_BHV7000-201_Pregnant_Partner_Patient_ICF_FRA_French_Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_BHV7000-201_Pregnant-Participant-ICF_HRV_Croatian_Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_BHV7000-201_Pregnant-Partner_ICF_ES_Spanish_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_BHV7000-201_Pregnant-Partner-and-Participant-ICF_DE_German_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_BHV7000-201_Pregnant-Partner-ICF_ES_Catalan_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_BHV7000-201_Pregnant-Partner-ICF_HRV_Croatian_Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_BHV7000-201_Pregnant-Partner-ICF_ROU_English_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_BHV7000-201_Pregnant-Partner-ICF_ROU_Romanian_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_BHV7000-201_Pregnant-Partner-ICF_SLO_Slovenian_Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_BHV7000-201_Pregnant-Partner-Participant-ICF_SK_Slovak_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_BHV7000-201_Pregnant-Subject-ICF_SLO_Slovenian_Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_BHV7000-201_SIS-and-ICF_Adults_NL_Dutch_Public | 4.0 |
| Subject information and informed consent form (for publication) | L1_BHV7000-201_SIS-and-ICF_Pregnancy_NL_Dutch_Public | 1.1 |
| Subject information and informed consent form (for publication) | L2_BHV7000-201_Concomitant Medication Diary Log_CZE_Czech_Public | 1.0 |
| Subject information and informed consent form (for publication) | L2_BHV7000-201_Concomitant Medication Paper Diary_SK_Slovak_Public | 1.0 |
| Subject information and informed consent form (for publication) | L2_BHV7000-201_Concomitant-Medication-Paper-Diary_HRV_Croatian_Public | 1.0 |
| Subject information and informed consent form (for publication) | L2_BHV7000-201_Concomitant-Medication-Paper-Diary_PT_Portuguese_Public | 1.0 |
| Subject information and informed consent form (for publication) | L2_BHV7000-201_ConMed-Paper-Diary_SLO_Slovenian_Public | 1.0 |
| Subject information and informed consent form (for publication) | L2_BHV7000-201_Country-Patient-Card_PT_Portuguese_Public | 1.0.2 |
| Subject information and informed consent form (for publication) | L2_BHV7000-201_Email-Comm_PT_Portuguese_Public | 1.0 |
| Subject information and informed consent form (for publication) | L2_BHV7000-201_Patient card_HU_Hungarian_Public | 1.0.0 |
| Subject information and informed consent form (for publication) | L2_BHV7000-201_Patient_Card_CZE_Czech_Public | 1.0.0 |
| Subject information and informed consent form (for publication) | L2_BHV7000-201_Patient_Card_FRA_French_Public | 1.0.0 |
| Subject information and informed consent form (for publication) | L2_BHV7000-201_Patient-Card_HRV_Croatian_Public | 1.0.1 |
| Subject information and informed consent form (for publication) | L2_BHV7000-201_PregnacyReminderCard_HRV_Croatian_Public | 1.0.1 |
| Subject information and informed consent form (for publication) | L2_BHV7000-201_Pregnancy-Reminder-Card_PT_Portuguese_Public | 3.0.0 |
| Subject information and informed consent form (for publication) | L2_BHV7000-201_Pregnant_Partner_ICF_IT_Italian_Public | 3.0 |
| Subject information and informed consent form (for publication) | L2_BHV7000-201_Reloadable-ScoutPass-Mailer_PT_Portuguese_Public | 1.0 |
| Subject information and informed consent form (for publication) | L2_BHV7000-201_SC_Email-Comm_HRV_Croatian_Public | 1 |
| Subject information and informed consent form (for publication) | L2_BHV7000-201_SC_Email-Comm_SLO_Slovenian_Public | 1.0 |
| Subject information and informed consent form (for publication) | L2_BHV7000-201_SC_PFD_Study-Brochure_HRV_Croatian_Public | 1.0 |
| Subject information and informed consent form (for publication) | L2_BHV7000-201_SC_PFD_Taxable-Payments-Letter_Template_HRV_Croatian_Public | 3.0 |
| Subject information and informed consent form (for publication) | L2_BHV7000-201_SC_Study-Brochure_SLO_Slovenian_Public | 1.0 |
| Subject information and informed consent form (for publication) | L2_BHV7000-201_SC_Taxable-Payments-Letter_SLO_Slovenian_Public | 3.0 |
| Subject information and informed consent form (for publication) | L2_BHV7000-201_Scout Clinical_Email communication_CZE_Czech_Public | 1.0 |
| Subject information and informed consent form (for publication) | L2_BHV7000-201_Scout Clinical_Study Brochure_CZE_Czech_Public | 1.0 |
| Subject information and informed consent form (for publication) | L2_BHV7000-201_Scout Clinical_Taxable Payments Letter_CZE_Czech_Public | 3.0 |
| Subject information and informed consent form (for publication) | L2_BHV7000-201_ScoutPass-Reloadable_PT_Portuguese_Public | 1.0 |
| Subject information and informed consent form (for publication) | L2_BHV7000-201_Site-and-Patient-Advocacy-Contact-List-for-ICF_AT_Public | N/A |
| Subject information and informed consent form (for publication) | L2_BHV7000-201_Study-Brochure_PT_Portuguese_Public | 1.0 |
| Subject information and informed consent form (for publication) | L3_BHV7000-201_Con Med Paper Diary_HUN Hungarian_Public | 1.0 |
| Subject information and informed consent form (for publication) | L3_BHV7000-201_Patient-Card_SK_Slovak_Public | 1.1.1 |
| Subject information and informed consent form (for publication) | L3_BHV7000-201_Pregnacy-Reminder-Card_SK_Slovak_Public | 1.0.1 |
| Subject information and informed consent form (for publication) | L3_BHV7000-201_Privacy_Annex_1_ICF_IT_Italian_Public | 3.0 |
| Synopsis of the protocol (for publication) | D1_Biohaven_BHV7000-201_Protocol lay language synopsis_2023-508813-18-00_CZE_Public | 1.3 |
| Synopsis of the protocol (for publication) | D1_Biohaven_BHV7000-201_Protocol lay language synopsis_2023-508813-18-00_DEU for BEL_Public | 1.3 |
| Synopsis of the protocol (for publication) | D1_Biohaven_BHV7000-201_Protocol lay language synopsis_2023-508813-18-00_ESP_Public | 1.3 |
| Synopsis of the protocol (for publication) | D1_Biohaven_BHV7000-201_Protocol lay language synopsis_2023-508813-18-00_FRA for BEL_Public | 1.3 |
| Synopsis of the protocol (for publication) | D1_Biohaven_BHV7000-201_Protocol lay language synopsis_2023-508813-18-00_FRA_Public | 1.3 |
| Synopsis of the protocol (for publication) | D1_Biohaven_BHV7000-201_Protocol lay language synopsis_2023-508813-18-00_GRC_Public | 1.3 |
| Synopsis of the protocol (for publication) | D1_Biohaven_BHV7000-201_Protocol lay language synopsis_2023-508813-18-00_HRV_Public | 1.3 |
| Synopsis of the protocol (for publication) | D1_Biohaven_BHV7000-201_Protocol lay language synopsis_2023-508813-18-00_HUN_Public | 1.3 |
| Synopsis of the protocol (for publication) | D1_Biohaven_BHV7000-201_Protocol lay language synopsis_2023-508813-18-00_ITA_Public | 1.3 |
| Synopsis of the protocol (for publication) | D1_Biohaven_BHV7000-201_Protocol lay language synopsis_2023-508813-18-00_NLD for BEL_Public | 1.3 |
| Synopsis of the protocol (for publication) | D1_Biohaven_BHV7000-201_Protocol lay language synopsis_2023-508813-18-00_NLD_Public | 1.3 |
| Synopsis of the protocol (for publication) | D1_Biohaven_BHV7000-201_Protocol lay language synopsis_2023-508813-18-00_POL_Public | 1.3 |
| Synopsis of the protocol (for publication) | D1_Biohaven_BHV7000-201_Protocol lay language synopsis_2023-508813-18-00_PRT_Public | 1.3 |
| Synopsis of the protocol (for publication) | D1_Biohaven_BHV7000-201_Protocol lay language synopsis_2023-508813-18-00_Public | 1.3 |
| Synopsis of the protocol (for publication) | D1_Biohaven_BHV7000-201_Protocol lay language synopsis_2023-508813-18-00_ROU_Public | 1.3 |
| Synopsis of the protocol (for publication) | D1_Biohaven_BHV7000-201_Protocol lay language synopsis_2023-508813-18-00_SVK_Public | 1.3 |
| Synopsis of the protocol (for publication) | D1_Biohaven_BHV7000-201_Protocol lay language synopsis_2023-508813-18-00_SVN_Public | 1.3 |
| Synopsis of the protocol (for publication) | D1_Biohaven_BHV7000-201_Protocol synopsis_2023-508813-18-00_DEU for AUT_Public | 1.3 |
Application history
19 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-06-14 | Finland | Acceptable 2024-10-07
|
2024-10-07 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-10-31 | Acceptable 2024-10-07
|
2024-10-31 | |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-11-06 | Acceptable 2024-10-07
|
2024-11-06 | |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2024-11-12 | Acceptable 2024-10-07
|
2024-11-12 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-11-15 | Acceptable | 2025-01-14 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-11-15 | Acceptable | 2024-12-06 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-11-20 | Acceptable | 2025-01-16 | |
| 8 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-11-22 | Acceptable | 2025-01-17 | |
| 9 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2025-01-21 | 2025-01-21 | ||
| 10 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-04-07 | Acceptable | 2025-05-13 | |
| 11 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-05-16 | Finland | Acceptable 2025-08-12
|
2025-08-12 |
| 12 | NON SUBSTANTIAL MODIFICATION | NSM-5 | 2025-09-12 | Finland | Acceptable 2025-08-12
|
2025-09-12 |
| 13 | SUBSTANTIAL MODIFICATION | SM-7 | 2025-10-16 | Finland | Acceptable with conditions 2026-02-02
|
2026-02-02 |
| 14 | SUBSTANTIAL MODIFICATION | SM-10 | 2026-02-11 | Acceptable with conditions | 2026-03-25 | |
| 15 | SUBSTANTIAL MODIFICATION | SM-8 | 2026-02-17 | Acceptable with conditions | 2026-03-23 | |
| 16 | SUBSTANTIAL MODIFICATION | SM-9 | 2026-02-23 | Acceptable with conditions | 2026-04-07 | |
| 17 | SUBSTANTIAL MODIFICATION | SM-11 | 2026-03-06 | Acceptable with conditions | 2026-03-18 | |
| 18 | SUBSTANTIAL MODIFICATION | SM-12 | 2026-04-21 | Acceptable with conditions | 2026-04-22 | |
| 19 | NON SUBSTANTIAL MODIFICATION | NSM-6 | 2026-05-21 | Acceptable with conditions | 2026-05-21 |