Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruitment ended
Participants planned
600
Countries
9
Sites
34
Lower limb spasticity
Evaluation of the efficacy and safety of 400 Units [U] of NT 201 in the treatment of adult lower limb spasticity involving the ankle plantar flexors
Key facts
- Sponsor
- Merz Pharmaceuticals GmbH
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Trial duration
- 3 Sep 2019 → ongoing
- Decision date (initial)
- 2024-08-02
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Merz Pharmaceuticals GmbH
External identifiers
- EU CT number
- 2023-505810-12-00
- EudraCT number
- 2018-001639-35
- ClinicalTrials.gov
- NCT03992404
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy, Safety, Efficacy
Evaluation of the efficacy and safety of 400 Units [U] of NT 201 in the treatment of adult lower limb spasticity involving the ankle plantar flexors
Secondary objectives 1
- Evaluation of the long-term safety of NT 201 in the treatment of spasticity with total body doses up to 800 U
Conditions and MedDRA coding
Lower limb spasticity
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10058977 | Spastic paresis | 10029205 |
Study design 3 periods
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Main Period / Screening Period Within 14 days prior to randomization.
|
Not Applicable | None | ||
| 2 | Main Period Placebo-controlled, double-blind treatment phase (1 treatment cycle)
|
Randomised Controlled | Double | [{"id":178250,"code":5,"name":"Carer"},{"id":178251,"code":1,"name":"Subject"},{"id":178252,"code":3,"name":"Monitor"},{"id":178253,"code":2,"name":"Investigator"},{"id":178254,"code":4,"name":"Analyst"}] | Xeomin (Main Period): Participants to receive intramuscular injection of Xeomin (400 units) into muscles of the lower limb. Placebo (Main Period): Participants to receive intramuscular placebo injection into muscles of the lower limb. |
| 3 | Open Label Extention Period (OLEX) 4-5 treatment cycles
|
Not Applicable | None | Xeomin (OLEX): All participants from the Main Period to receive intramuscular injections of Xeomin (up to 800 units) into muscles of the lower limb and upper limb, if indicated. |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 7
- Female or male subject ≥ 18 years and ≤ 85 years at screening
- Diagnosis of lower limb spasticity with or without upper limb spasticity of the same body side caused by stroke or traumatic brain injury
- Disabling ankle flexor spasticity presenting as pes equinus or pes equinovarus
- Modified Ashworth Scale-Bohannon [MAS] score of 2 or 3 points in the ankle plantar flexor of the target lower limb (supine position, knee extended)
- Minimum passive range of motion in ankle of the target lower limb (supine position, knee extended): 10°dorsiflexion and 20°plantarflexion
- At least 4 months since last botulinum neurotoxin [BoNT] injection for treatment of spasticity or any other condition
- For subjects receiving anticoagulation therapy, the investigator confirms and documents that the subject has an: o Activated partial thromboplastin time [aPTT] ≤ 80 seconds (subjects on dabigatran or other direct thrombin inhibitors) or o International normalized ratio [INR] value of ≤ 2.5 (subjects on coumarins or other anticoagulants monitored by INR).
Exclusion criteria 11
- Generalized disorders of muscle activity (e.g., myasthenia gravis, Lambert-Eaton syndrome, amyotrophic lateral sclerosis) or any other significant peripheral neuromuscular dysfunction which might interfere with the study
- Bilateral lower limb paresis/paralysis/spasticity or tetraparesis/paralysis/spasticity
- Body weight < 50 kg
- Severe atrophy of the target limb muscles
- Previous, ongoing or planned treatments of spasticity with intrathecal baclofen
- Previous, ongoing, or planned treatments of spasticity in the target lower limb with any of the following procedures: o Surgical intervention o Alcohol or phenol block o Muscle afferent block
- Physiotherapy or use of orthoses or splints at the target limb initiated less than 4 weeks before screening or expected to change during the double-blind phase of the study
- Current or planned treatment with parenterally administered drugs that interfere with neuromuscular transmission (e.g., intrathecal baclofen, tubocurarine-type muscle relaxants used in anesthesia), or local anesthetics in the treated region within 2 weeks prior to screening
- Infection or inflammation at the injection sites
- Subjects with presence or history of aspiration pneumonia, recurrent lower respiratory tract infections, or compromised respiratory function as per investigator's clinical judgment
- Pregnancy (as verified by a positive pregnancy test) or breast feeding.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 3
- Change from baseline in derived MAS ankle score (knee extended) at Weeks 4 to 6 (using a value modelled from the actual values measured at Week 4 [V3] and Week 6 [V4])
- GICS assessed by physician at Week 4 to 6 (using a value modelled from the actual values measured at Week 4 [V3] and Week 6 [V4]) (co-primary for US regulatory authority only, otherwise secondary).
- Primary safety variable: • Occurrence of treatment emergent adverse events [TEAEs] in Main Period.
Secondary endpoints 3
- Key secondary efficacy variable: Change from Study Baseline in Goal Attainment Scale [GAS] at Week 6 (V4)
- GICS assessed by subject at Week 4 (V3) to Week 6 (V4)
- GICS assessed by caregiver at Week 4 (V3) to Week 6 (V4).
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 10
XEOMIN 200 unités, poudre pour solution injectable
PRD4411682 · Product
- Active substance
- Clostridium Botulinum Neurotoxin Type a (150KD), Free of Complexing Proteins
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAMUSCULAR INJECTION
- Max daily dose
- 800 U unit(s)
- Max total dose
- 800 U unit(s)
- Max treatment duration
- 92 Week(s)
- Authorisation status
- Authorised
- ATC code
- M03AX01 — BOTULINUM TOXIN
- Marketing authorisation
- 34009 550 221 5 2
- MA holder
- MERZ PHARMACEUTICALS GMBH
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Trial specific labelling
XEOMIN, 200 jednostek, proszek do sporządzania roztworu do wstrzykiwań
PRD4574446 · Product
- Active substance
- Clostridium Botulinum Neurotoxin Type a (150KD), Free of Complexing Proteins
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAMUSCULAR INJECTION
- Max daily dose
- 800 U unit(s)
- Max total dose
- 800 U unit(s)
- Max treatment duration
- 92 Week(s)
- Authorisation status
- Authorised
- ATC code
- M03AX01 — BOTULINUM TOXIN
- Marketing authorisation
- 23378
- MA holder
- MERZ PHARMACEUTICALS GMBH
- MA country
- Poland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Trial specific labelling
XEOMEEN 200 unités poudre pour solution injectable
PRD4061561 · Product
- Active substance
- Clostridium Botulinum Neurotoxin Type a (150KD), Free of Complexing Proteins
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAMUSCULAR INJECTION
- Max daily dose
- 800 U unit(s)
- Max total dose
- 800 U unit(s)
- Max treatment duration
- 92 Week(s)
- Authorisation status
- Authorised
- ATC code
- M03AX01 — BOTULINUM TOXIN
- Marketing authorisation
- BE494631
- MA holder
- MERZ PHARMACEUTICALS GMBH
- MA country
- Belgium
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Trial specific labelling
XEOMIN 200 jednotiek prášok na injekčný roztok
PRD4185010 · Product
- Active substance
- Clostridium Botulinum Neurotoxin Type a (150KD), Free of Complexing Proteins
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAMUSCULAR INJECTION
- Max daily dose
- 800 U unit(s)
- Max total dose
- 800 U unit(s)
- Max treatment duration
- 92 Week(s)
- Authorisation status
- Authorised
- ATC code
- M03AX01 — BOTULINUM TOXIN
- Marketing authorisation
- 63/0282/16-S
- MA holder
- MERZ PHARMACEUTICALS GMBH
- MA country
- Slovakia
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Trial specific labelling
XEOMIN 200 jednotek prášek pro injekční roztok
PRD4185008 · Product
- Active substance
- Clostridium Botulinum Neurotoxin Type a (150KD), Free of Complexing Proteins
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAMUSCULAR INJECTION
- Max daily dose
- 800 U unit(s)
- Max total dose
- 800 U unit(s)
- Max treatment duration
- 92 Week(s)
- Authorisation status
- Authorised
- ATC code
- M03AX01 — BOTULINUM TOXIN
- Marketing authorisation
- 63/257/16-C
- MA holder
- MERZ PHARMACEUTICALS GMBH
- MA country
- Czech Republic
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Trial specific labelling
XEOMIN 200 Einheiten Pulver zur Herstellung einer Injektionslösung
PRD4185137 · Product
- Active substance
- Clostridium Botulinum Neurotoxin Type a (150KD), Free of Complexing Proteins
- Substance synonyms
- IncobotulinumtoxinA, NT 201, Botulinum toxin type A (150 kD), free from complexing proteins
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAMUSCULAR INJECTION
- Max daily dose
- 800 U unit(s)
- Max total dose
- 800 U unit(s)
- Max treatment duration
- 92 Week(s)
- Authorisation status
- Authorised
- ATC code
- M03AX01 — BOTULINUM TOXIN
- Marketing authorisation
- 92833.00.00
- MA holder
- MERZ PHARMACEUTICALS GMBH
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Trial specific labelling
XEOMIN 200 egység por oldatos injekcióhoz
PRD4088601 · Product
- Active substance
- Clostridium Botulinum Neurotoxin Type a (150KD), Free of Complexing Proteins
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAMUSCULAR INJECTION
- Max daily dose
- 800 U unit(s)
- Max total dose
- 800 U unit(s)
- Max treatment duration
- 92 Week(s)
- Authorisation status
- Authorised
- ATC code
- M03AX01 — BOTULINUM TOXIN
- Marketing authorisation
- OGYI-T-22593/03
- MA holder
- MERZ PHARMACEUTICALS GMBH
- MA country
- Hungary
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Trial specific labelling
XEOMIN 200 unidades polvo para solución inyectable
PRD10941713 · Product
- Active substance
- Clostridium Botulinum Neurotoxin Type a (150KD), Free of Complexing Proteins
- Substance synonyms
- IncobotulinumtoxinA, NT 201, Botulinum toxin type A (150 kD), free from complexing proteins
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAMUSCULAR INJECTION
- Max daily dose
- 800 U unit(s)
- Max total dose
- 800 U unit(s)
- Max treatment duration
- 92 Week(s)
- Authorisation status
- Authorised
- ATC code
- M03AX01 — BOTULINUM TOXIN
- Marketing authorisation
- 80801
- MA holder
- MERZ PHARMACEUTICALS GMBH
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Trial specific labelling
XEOMEEN 200 eenheden poeder voor oplossing voor injectie
PRD4051904 · Product
- Active substance
- Clostridium Botulinum Neurotoxin Type a (150KD), Free of Complexing Proteins
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAMUSCULAR INJECTION
- Max daily dose
- 800 U unit(s)
- Max total dose
- 800 U unit(s)
- Max treatment duration
- 92 Week(s)
- Authorisation status
- Authorised
- ATC code
- M03AX01 — BOTULINUM TOXIN
- Marketing authorisation
- BE494631
- MA holder
- MERZ PHARMACEUTICALS GMBH
- MA country
- Belgium
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Trial specific labelling
XEOMIN, 200 unità, polvere per soluzione iniettabile
PRD4360320 · Product
- Active substance
- Clostridium Botulinum Neurotoxin Type a (150KD), Free of Complexing Proteins
- Substance synonyms
- IncobotulinumtoxinA, NT 201, Botulinum toxin type A (150 kD), free from complexing proteins
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAMUSCULAR INJECTION
- Max daily dose
- 800 U unit(s)
- Max total dose
- 800 U unit(s)
- Max treatment duration
- 92 Week(s)
- Authorisation status
- Authorised
- ATC code
- M03AX01 — BOTULINUM TOXIN
- Marketing authorisation
- 038232106
- MA holder
- MERZ PHARMACEUTICALS GMBH
- MA country
- Italy
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Trial specific labelling
Placebo 1
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Merz Pharmaceuticals GmbH
- Sponsor organisation
- Merz Pharmaceuticals GmbH
- Address
- Eckenheimer Landstrasse 100, Nordend-West Nordend-West
- City
- Frankfurt Am Main
- Postcode
- 60318
- Country
- Germany
Scientific contact point
- Organisation
- Merz Pharmaceuticals GmbH
- Contact name
- Contact Point Clinical Trials
Public contact point
- Organisation
- Merz Pharmaceuticals GmbH
- Contact name
- Contact Point Clinical Trials
Third parties 9
| Organisation | City, country | Duties |
|---|---|---|
| Toxologics GmbH ORG-100049327
|
Hanover, Germany | Laboratory analysis |
| Eurofins BioPharma Product Testing Munich GmbH ORG-100011574
|
Planegg, Germany | Laboratory analysis |
| Metronomia Clinical Research GmbH ORG-100012892
|
Munich, Germany | Code 10, Data management, E-data capture |
| WCT Worldwide Clinical Trials GER GmbH ORG-100049321
|
Berlin, Germany | On site monitoring, Code 12, Code 2, Code 5, Code 8 |
| Almac Clinical Services (Ireland) Limited ORG-100033336
|
Dundalk, Ireland | Code 14 |
| MEDPACE LABORATORIES ORG-100042942
|
Leuven, Belgium | Laboratory analysis |
| Almac Group Limited ORG-100011829
|
Craigavon, United Kingdom (Northern Ireland) | Code 14 |
| Almac Clinical Technologies LLC ORG-100043036
|
Souderton, United States | Interactive response technologies (IRT) |
| Infraserv GmbH & Co. Hoechst KG ORG-100045192
|
Frankfurt Am Main, Germany | Other |
Locations
9 EU/EEA countries · 34 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ended | 12 | 2 |
| Czechia | Ongoing, recruitment ended | 60 | 3 |
| France | Ongoing, recruitment ended | 10 | 5 |
| Germany | Ongoing, recruitment ended | 38 | 6 |
| Hungary | Ended | 12 | 3 |
| Italy | Ongoing, recruitment ended | 16 | 3 |
| Poland | Ongoing, recruitment ended | 155 | 7 |
| Slovakia | Ongoing, recruitment ended | 18 | 2 |
| Spain | Ongoing, recruitment ended | 22 | 3 |
| Rest of world
Ukraine, Switzerland, Canada, United States, United Kingdom
|
— | 257 | — |
Investigational sites
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur
Physical medicine and rehabilitation department, Avenue Docteur Gaston Therasse 1, 5530, Yvoir
Chu Brugmann
Neurology, Arthur Van Gehuchtenplein 4, 1020, Brussels
Neurologie a rehabilitace Skopalikova
Neurology, Skopalikova 6, 615 00, Brno
Nemocnice Pardubickeho kraje a.s.
Neurology, Kyjevska 44 Pardubicky, 530 03, Pardubice
Fakultni Nemocnice Ostrava
Neurology, 17. Listopadu 1790/5, Poruba, Ostrava
Raymond-Poincare Hospital
Service de MPR Pôle Handicap-Rééducation, 104 Boulevard Raymond Poincare, 92380, Garches
Les Hopitaux Universitaires De Strasbourg
Service de MPR, 1 Place De L Hopital, Cs 80426, Strasbourg Cedex
Centre Hospitalier Universitaire De Lille
Service de MPR, 2 Avenue Oscar Lambret, Cs 70001, Lille Cedex
Saint Helier
Service de MPR, 54 Rue Saint Helier, 35000, Rennes
Centre Hospitalier Universitaire De Toulouse
Médecine physique et de réadaptation Pôle neurosciences, 1 Place Du Docteur Joseph Baylac, 31300, Toulouse
Universitaetsklinikum Bonn AöR
Klinik für Neurodegenerative Erkrankungen und Gerontopsychiatrie, Venusberg-Campus 1, Venusberg, Bonn
Universitaetsklinikum Aachen AöR
Klinik für Neurologie, Pauwelsstrasse 30, 52074, Aachen
Universitaetsklinikum Duesseldorf AöR
Klinik für Neurologie, Moorenstrasse 5, Bilk, Duesseldorf
University Medical Center Hamburg-Eppendorf
Klinik und Poliklinik für Neurologie, Kopf- und Neurozentrum, Martinistrasse 52, Eppendorf, Hamburg
DKD HELIOS Klinik Wiesbaden GmbH
Fachbereich Neurologie, Aukammallee 33, Bierstadt, Wiesbaden
Universitaetsklinikum Wuerzburg AöR
Neurologische Klinik und Poliklinik des Universitätsklinikums Würzburg, Kopfkliniken, Josef-Schneider-Strasse 2, Grombuehl, Wuerzburg
Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz
Neurológiai Osztály és Stroke Részleg, Vasvari Pal Utca 2-4, 9024, Gyor
Szent Damjan Goeroegkatolikus Korhaz
Neurológiai és Stroke Osztály, Arpad Utca 26, 4600, Kisvarda
University Of Szeged
Department of Neurology, Semmelweis Utca 6, 6725, Szeged
IRCCS Ospedale Policlinico San Martino
U.O.Complessa Riabilitazione e Rieducazione Funzionale, Largo Rosanna Benzi 10, 16132, Genoa
Azienda Ospedaliero Universitaria Ospedali Riuniti
Dipartimento Assistenzionale Integrato (DAI) di Neuriscienze, Viale Luigi Pinto 1, 71122, Foggia
Azienda Ospedaliero-Universitaria Maggiore Della Carita
Dipartimento di Medicina fisica e Riabilitativa, Corso Giuseppe Mazzini 18, 28100, Novara
Indywidualna Praktyka lekarska Dr. hab. n. med. Anna Szczepańska-Szerej
NA, ul. Onyksowa 12, 20-582, Lublin
NeuroKlinika Gabinet Lekarski Prof. Andrzej Bogucki
NA, Ul. Andrzeja Struga 49/51, 90-640, Łódź
Neuryt Diagnostyka I Terapia Neurologiczna
NA, Ul. Koszarowa 5, 51-149, Wroclaw
Instytut Psychiatrii I Neurologii
II Klinika Neurologiczna, Ul. Jana III Sobieskiego 9, 02-957, Warsaw
Specjalistyczne Gabinety Sp. z o.o.
NA, Pl. Lasoty 4, 30-539, Cracow
Centrum Kompleksowej Rehabilitacji Sp. z o.o.
Filia 7, Wawrzyńca Surowieckiego 8, 02-783, Warsaw
Project Samodzielni Sp.z.o.o
NA, ul. Korotyńskiego 5/U3, 02-121, Warsaw
Fakultna Nemocnica Trnava
Neurology, Andreja Zarnova 11, 917 02, Trnava
University Hospital Bratislava
Neurology, Limbova 5, Nove Mesto, Bratislava
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 |
|---|---|---|---|---|---|
| Belgium | 2020-01-06 | 2026-03-30 | 2021-05-12 | 2025-05-05 | |
| Czechia | 2019-10-21 | 2019-11-11 | 2025-05-05 | ||
| France | 2020-02-14 | 2022-11-18 | 2025-05-05 | ||
| Germany | 2020-01-17 | 2020-03-02 | 2025-05-05 | ||
| Hungary | 2022-12-19 | 2025-09-25 | 2023-01-24 | 2025-05-05 | |
| Italy | 2019-10-22 | 2021-07-21 | 2025-05-05 | ||
| Poland | 2019-09-03 | 2019-09-16 | 2025-05-05 | ||
| Slovakia | 2023-06-01 | 2023-07-06 | 2025-05-05 | ||
| Spain | 2019-09-12 | 2019-11-29 | 2025-05-05 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 74 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2023-505810-12-00 | 6 |
| Protocol (for publication) | D4_Patient facing documents_CZE_Scale_GICS | 1.0 |
| Protocol (for publication) | D4_Patient facing documents_DEU_Scale_GICS | 1.0 |
| Protocol (for publication) | D4_Patient facing documents_EQ-5D-5L_placeholder | 1 |
| Protocol (for publication) | D4_Patient facing documents_ESP_Scale_GICS | 1.0 |
| Protocol (for publication) | D4_Patient facing documents_FRA_Scale_GICS | 1.0 |
| Protocol (for publication) | D4_Patient facing documents_GAS_placeholder | 1 |
| Protocol (for publication) | D4_Patient facing documents_ITA_Scale_GICS | 1.0 |
| Protocol (for publication) | D4_Patient facing documents_POL_Scale_GICS | 1.0 |
| Protocol (for publication) | D4_Patient facing documents_Scale_BEL-fr_GICS | 1.0 |
| Protocol (for publication) | D4_Patient facing documents_Scale_BEL-nl_GICS | 1.0 |
| Protocol (for publication) | D4_Patient facing documents_Scale_GICS_EN | 1.0 |
| Protocol (for publication) | D4_Patient facing documents_SVK_Scale_GICS | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements | NA |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements | NA |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements | N/A |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements | n/a |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements | NA |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements_placeholder | NA |
| Recruitment arrangements (for publication) | K1_Recruitment procedure_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_DEU_Caregiver ICF_Redacted | 4.1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_DEU_Subject ICF_Redacted | 5.1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_ESP_Caregiver ICF_Redacted | 4.1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_ESP_Subject ICF_Redacted | 5.2 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_FRA_Caregiver ICF_Redacted | 4.1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_FRA_Caregiver PIS_Redacted | 4.1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_FRA_Subject ICF_Redacted | 5.1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_FRA_Subject PIS_Redacted | 5.1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_HUN_Caregiver ICF_Redacted | 4.2 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_HUN_Caregiver PIS_Redacted | 4.2 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_HUN_Subject ICF_Redacted | 5.2 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_HUN_Subject PIS_Redacted | 5.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF CZE Caregiver ICF_Redacted | 4.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF CZE GDPR ICF_Redacted | 5.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF CZE Main ICF_Redacted | 5.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_BEL_Caregiver ICF_Flemish_Redacted | 4.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_BEL_Caregiver ICF_Fr_Redacted | 4.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_BEL_Subject ICF_Flemish_Redacted | 5.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_BEL_Subject ICF_Fr_Redacted | 5.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_caregiver_Redacted | 4.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_POL_Caregiver_ICF_Redacted | 4.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_POL_Subject_ICF_Redacted | 5.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Subject_Redacted | 5.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_SVK_ Caregiver ICF_Redacted | 4.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_SVK_ Subject ICF_Redacted | 5.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_SVK_GDPR ICF_Redacted | 5.2 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Longboat Patient Recruitment Website Print_Public | 1.0 |
| Subject information and informed consent form (for publication) | L2_Patient facing documents_HUN_Scale_EQ-5D-5L_placeholder | n/a |
| Subject information and informed consent form (for publication) | L2_Patient facing documents_HUN_Scale_GAS_placeholder | n/a |
| Subject information and informed consent form (for publication) | L2_Patient facing documents_HUN_Scale_GISC_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L3_List of documents in Part II_HU | n/a |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC_Xeomin_BE (fr) | 37.0 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC_Xeomin_BE (nl) | 37.0 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC_Xeomin_CZ | 37.0 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC_Xeomin_DE | 37.0 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC_Xeomin_ES | 37.0 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC_Xeomin_FR | 37.0 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC_Xeomin_HU | 35 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC_Xeomin_IT | 37.0 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC_Xeomin_PL | 37.0 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC_Xeomin_SK | 37.0 |
| Synopsis of the protocol (for publication) | D1 Protocol Synopsis_ITA_2023-505810-12-00 | 6.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis ES_2023-505810-12-00 | 6.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_BEL_de_2023-505810-12-00 | 6.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_BEL-fr_2023-505810-12-00 | 6.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_BEL-nl_2023-505810-12-00 | 6.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_CZE_2023-505810-12-00 | 6.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_DEU_2023-505810-12-00 | 6.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_FRA_2023-505810-12-00 | 6.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_HUN_2023-505810-12-00 | 6.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_POL_2023-505810-12-00 | 6.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_SVK_2023-505810-12-00 | 6.0 |
Application history
7 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-07-05 | Germany | Acceptable 2024-08-02
|
2024-08-02 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-09-18 | Acceptable | 2024-10-22 | |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-03-21 | Germany | Acceptable | 2025-03-21 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-07-31 | Acceptable | 2025-07-31 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-09-12 | Acceptable | 2025-10-29 | |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2026-03-23 | Germany | Acceptable | 2026-03-23 |
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2026-03-24 | Germany | Acceptable | 2026-03-24 |