Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ended
Participants planned
248
Countries
7
Sites
26
Masseter Muscle Prominence
To compare the efficacy and safety of BOTOX with placebo for treatment in subjects with masseter muscle prominence (MMP)
Key facts
- Sponsor
- Abbvie Deutschland GmbH & Co. KG
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Not possible to specify
- Trial duration
- 11 Oct 2023 → 29 Oct 2025
- Decision date (initial)
- 2023-02-06
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Efficacy
To compare the efficacy and safety of BOTOX with placebo for treatment in subjects with masseter muscle prominence (MMP)
Conditions and MedDRA coding
Masseter Muscle Prominence
Study design 2 periods
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Period 1 (Days 1 through 180) Period 1 is a double-blind, randomized, placebo-controlled, single treatment design, which will assess the safety and efficacy of BOTOX treatment of MMP. On Day 180 visit, the final Period 1 assessments will be collected, after which all eligible subjects who are willing to undergo retreatment will continue into Period 2
|
Randomised Controlled | Double | [{"id":158179,"code":2,"name":"Investigator"},{"id":158178,"code":1,"name":"Subject"}] | Period 1 Arm 1: Eligible subjects will be randomized to receive BOTOX 48 U Period 1 Arm 2: Eligible subjects will be randomized to receive placebo |
| 2 | Period 2 (Days 180 through 360) Period 2 is an open-label treatment and safety follow up period which, comprises of 1 retreatment at the Day 180 visit, if the subject meets retreatment criteria and is willing to undergo retreatment, and 6 months of safety follow-up post retreatment. In this study, the term "retreatment" indicates that subjects randomized to BOTOX in Period 1 receive BOTOX retreatment and for subjects randomized to placebo in Period 1 receive first BOTOX treatment
|
Not Applicable | None | Period 2 Arm 1: Eligible subjects will be randomized to receive Botox |
Regulatory references
- Scientific advice from competent authorities
- European Medicines Agency
- Plan to share IPD
- Yes
- IPD plan description
- AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information. To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/ For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 2
- Body mass index using the calculation: BMI = weight (kg)/height (m)2, rounded to the nearest whole number.
- • Bilateral MMP (identical grades for left and right sides of the face), as determined at screening and at the Day 1 visit by the investigator. • Bilateral MMP (identical grades for left and right sides of the face), as determined at the Day 1 visit by the subject. • MMP grades, as assessed by investigator and subject, with bilateral symmetry at Day 1.
Exclusion criteria 9
- Subject has current intraoral infection, including infection of the mouth or gums, or facial skin infection requiring medical treatment in the opinion of the investigator.
- Prior exposure to botulinum toxin of any serotype to any part of the body (not including masseter muscle) within the 3 months prior to Day 1.
- History of or current TMJD, or presence of signs/symptoms of possible TMJD in the opinion of the investigator.
- Subject has weakness of the masseter, pterygoid, or temporalis muscles due to trauma, facial nerve injury, or other condition that could interfere with normal chewing and jaw clenching, as determined by the investigator.
- Excess lower facial fat, jowling, loose or lax skin in lower face, or parotid gland prominence that could interfere with MMPS or MMPS-P grading, as determined by the investigator.
- Medical condition that may put the subject at increased medical risk with exposure to BOTOX, including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other condition that might interfere with neuromuscular function.
- History of dental or surgical procedure for lower facial shaping or masseter muscle reduction.
- No history of any permanent soft tissue fillers in the jawline.
- No history of any semi-permanent soft tissue fillers, HA fillers, or autologous fat in the jawline within 24 months prior to Day 1.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- Achievement of MMPS ≥ 2-grade improvement from baseline at Day 90, per investigator assessment of MMP
- Achievement of MMPS-P ≥ 2-grade improvement from baseline at Day 90, per subject assessment of MMP
Secondary endpoints 8
- Response on the LFSQ-TXSAT follow-up version at Day 90
- Response of on the BIA-MMP at Day 90
- Change from baseline in lower facial volume (cm3) at Day 90, calculated from standardized images
- Change from baseline in lower facial width (mm) at Day 90, calculated from standardized images
- Change from baseline in Lower Facial Shape Questionnaire - Impact Assessment (LFSQ-IA) summary score at Day 90
- Response of on the LFSQ-TXSAT follow-up version
- Response on the BIA-MMP
- Change from baseline in LFSQ-IA summary score
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
BOTOX 100 Allergan Units Powder for Solution for Injection
PRD9814936 · Product
- Active substance
- Botulinum Toxin Type A
- Substance synonyms
- Onaclostox, Botulinum toxin, type A, purified neurotoxin component, OnabotulinumtoxinA, BOTULINUM TOXIN A, BOTULIN TOXIN A
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAMUSCULAR INJECTION
- Max daily dose
- 48 IU international unit(s)
- Max total dose
- 48 IU international unit(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- M03AX01 — BOTULINUM TOXIN
- Marketing authorisation
- PA 1824/17/1
- MA holder
- ABBVIE LIMITED
- MA country
- Ireland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Botox will be packaged in a masked/blinded manner to look similar to the placebo packaging
Placebo 1
Placebo for Botox - Solution for Injection
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
Abbvie Deutschland GmbH & Co. KG
- Sponsor organisation
- Abbvie Deutschland GmbH & Co. KG
- Address
- Knollstrasse
- City
- Ludwigshafen Am Rhein
- Postcode
- 67061
- Country
- Germany
Scientific contact point
- Organisation
- Abbvie Deutschland GmbH & Co. KG
- Contact name
- Global Clinial Trial Helpdesk
Public contact point
- Organisation
- Abbvie Deutschland GmbH & Co. KG
- Contact name
- Global Clinial Trial Helpdesk
Third parties 3
| Organisation | City, country | Duties |
|---|---|---|
| Canfield Scientific Inc. ORG-100042834
|
Parsippany, United States | Other |
| Labcorp Endpoint Clinical Inc. ORG-100040567
|
Wakefield, United States | Interactive response technologies (IRT) |
| Medidata Solutions Inc. ORG-100016256
|
New York, United States | Other, E-data capture |
Locations
7 EU/EEA countries · 26 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ended | 30 | 4 |
| Bulgaria | Ended | 26 | 3 |
| France | Ended | 38 | 5 |
| Germany | Ended | 42 | 6 |
| Italy | Ended | 23 | 3 |
| Netherlands | Ended | 11 | 1 |
| Spain | Ended | 29 | 4 |
| Rest of world
United Kingdom
|
— | 49 | — |
Investigational sites
Estheticare
Evolve Clinic, Turnhoutsebaan 210, 2970, Schilde
UZ Brussel
Dermatology, Laarbeeklaan 101, 1090, Jette
Dermatologie Kempenland
Davinciclinic, Kempenlaan 36, 2340, Beerse
Aesthics
Lightfalls Clinic, Regenboog 1, 9090, Melle
Medical Center Derma Vita EOOD
Medical Center Derma Vita EOOD, Ulitsa Akad. Ivan Buresh 8, 1407, Sofiya
Medical Center Dermatologia D-R Denkova EOOD
Medical Center Dermatology Dr. Denkova EOOD, Bulevard Simeonovsko Shose 62, Fl. 2, Sofiya
Dermavist Group Practice For Specialized Medical Aid For Skin Diseases Ltd.
Dermavist Group Practice For Specialized Medical Aid For Skin Diseases Ltd., Bulevard Maritsa 25, 4000, Plovdiv
Docteur Belhaouari
Cabinet de Chirurgie Plastique et Esthetique, 3 Allees Jules Guesde, 31000, Toulouse
Bodokh Isaac
Cabinet Dermatologie, 109 Rue D Antibes, 06400, Cannes
Selarl Du Dr Laurence Benouaiche
Cabinet medical de Chirurgie Plastique et Esthetique, 8 Rue De Solferino, 75007, Paris
Global Esthetic
Centre médical de médecine esthétique, 56 Avenue Victor Hugo, 75116, Paris
Mediti S.A.S.
Chirurgie esthétique, 90 Boulevard Francis Meilland, 06160, Antibes
Privatpraxis Dr. Hilton & Partner
Privatpraxis Dr. Hilton & Partner, Huschbergerstrasse 20, 40212, Duesseldorf
Hautzentrum Köln
Hautzentrum Köln, Schillingsrotter Strasse 39-41, 50996, Cologne
Privatpraxis Dr. Hilton & Partner
Privatpraxis Dr. Hilton & Partner, Gruenstrasse 6, 40212, Duesseldorf
Hautok and Hautok-Cosmetics
Hautok and Hautok-Cosmetics, Residenzstrasse 7, 80333, Munich
Hamburg University
Department of Chemistry - Institute for Biochemistry and Molecular Biology, Papendamm 21, Rotherbaum, Hamburg
Studienzentrum Theatiner46
Studienzentrum Theatiner46, Theatinerstrasse 46, 80333, Munich
ASL Di Latina
Ospedale A. Florini di Terracina, Dermatologia, Girasoli, Via P. Nervi Torre 2, Latina
Centro Ricerche Cliniche Di Verona S.r.l.
Centro Ricerche Cliniche Di Versona S.r.l., Piazzale Ludovico Antonio Scuro 10, 37134, Verona
Fondazione Policlinico Universitario Campus Bio-Medico
U.O.C. di Chirurgia Plastica Ricostruttiva ed Estetica e Dermatologia, Via Alvaro Del Portillo N 200, 00128, Rome
Doctors at Soap B.V.
Doctors at Soap B.V., Van Baerlestraat 122, 1071 BD, Amsterdam
Grupo Dermatologico Y Estetico Pedro Jaen S.A.
Grupo Dermatologico y Estetico Pedro Jaen, Calle De Serrano 143, 28006, Madrid
Gavin Dermatologos Vigo S.L.P.
Gavin Dermatologos, Calle Urzaiz 33, 36201, Vigo
Clinica Robega
Clinica Robega, Calle Ferraz 40 Local, 28008, Madrid
Clinica Alejandria
Clinica Alejandria, Calle Sorni 12 Bajo Interior, 46004, Valencia
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 | 2023-12-14 | 2025-06-27 | 2024-04-03 | 2024-12-03 | |
| Bulgaria | 2023-10-13 | 2025-11-06 | 2023-10-17 | 2024-12-03 | |
| France | 2024-01-31 | 2025-10-29 | 2024-02-23 | 2024-12-03 | |
| Germany | 2023-10-17 | 2025-11-12 | 2023-10-17 | 2024-12-03 | |
| Italy | 2023-11-07 | 2025-11-13 | 2023-12-12 | 2024-12-03 | |
| Spain | 2023-10-11 | 2025-11-19 | 2023-10-25 | 2024-12-03 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 113 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | m23-123 protocol_Public_Redacted | 7.0 |
| Recruitment arrangements (for publication) | 22-123 BG Recruitment and ICF Procedures Public | 1.0 |
| Recruitment arrangements (for publication) | K2 M23-123 DE Ad and Recruitment German Poster 3_Public | 1.0 |
| Recruitment arrangements (for publication) | K2 M23-123 DE Ad and Recruitment German Poster 4_Public | 1.0 |
| Recruitment arrangements (for publication) | K2 M23-123 DE Ad and Recruitment German Poster 5_Public | 1.0 |
| Recruitment arrangements (for publication) | K2 M23-123 DE Ad and Recruitment German Poster 6_Public | 1.0 |
| Recruitment arrangements (for publication) | K2 M23-123 IT Recruitment Poster 3 _Public | 1 |
| Recruitment arrangements (for publication) | K2 M23-123 IT Recruitment Poster 4 _Public | 1 |
| Recruitment arrangements (for publication) | K2 M23-123 IT Recruitment Poster 5_Public | 1 |
| Recruitment arrangements (for publication) | K2 M23-123 IT Recruitment Poster 6_Public | 1 |
| Recruitment arrangements (for publication) | K2_M23-123 BE Poster 3 Dutch Public | 1.0 |
| Recruitment arrangements (for publication) | K2_M23-123 BE Poster 3 English Public | 1.0 |
| Recruitment arrangements (for publication) | K2_M23-123 BE Poster 3 French Public | 1.0 |
| Recruitment arrangements (for publication) | K2_M23-123 BE Poster 4 Dutch Public | 1.0 |
| Recruitment arrangements (for publication) | K2_M23-123 BE Poster 4 English Public | 1.0 |
| Recruitment arrangements (for publication) | K2_M23-123 BE Poster 4 French Public | 1.0 |
| Recruitment arrangements (for publication) | K2_M23-123 BE Poster 5 Dutch Public | 1.0 |
| Recruitment arrangements (for publication) | K2_M23-123 BE Poster 5 French Public | 1.0 |
| Recruitment arrangements (for publication) | K2_M23-123 BE Poster 6 English Public | 1.0 |
| Recruitment arrangements (for publication) | K2_M23-123 BE Poster 6 French Public | 1.0 |
| Recruitment arrangements (for publication) | K2_M23-123 BE Recruitment Material - Search Ads Dutch public | 1.0 |
| Recruitment arrangements (for publication) | K2_M23-123 BE Recruitment Material - Search Ads English public | 1.0 |
| Recruitment arrangements (for publication) | K2_M23-123 BE Recruitment Material - Search Ads French public | 1.0 |
| Recruitment arrangements (for publication) | K2_M23-123 BG Recruitment Material - Search Ads Public | 1.0 |
| Recruitment arrangements (for publication) | K2_M23-123 BG Recruitment Poster_3_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_M23-123 BG Recruitment Poster_4_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_M23-123 BG Recruitment Poster_5_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_M23-123 BG Recruitment Poster_6_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_M23-123 DE Recruitment Material - Search Ads public | 1.0 |
| Recruitment arrangements (for publication) | K2_M23-123 FR Recruitment Material - Search Ads Public | 1.0 |
| Recruitment arrangements (for publication) | K2_M23-123 FR Recruitment Poster 3_Public | 1 |
| Recruitment arrangements (for publication) | K2_M23-123 FR Recruitment Poster 4_Public | 1 |
| Recruitment arrangements (for publication) | K2_M23-123 FR Recruitment Poster 5_Public | 1 |
| Recruitment arrangements (for publication) | K2_M23-123 FR Recruitment Poster 6_Public | 1 |
| Recruitment arrangements (for publication) | K2_M23-123 IT Recruitment Material - Search Ads public | 1.0 |
| Recruitment arrangements (for publication) | K2_M23-123 Poster 5 English Public | 1.0 |
| Recruitment arrangements (for publication) | K2_M23-123 Poster 6 Dutch Public | 1.0 |
| Recruitment arrangements (for publication) | K2_M23-123_ES_Recruitment Poster 3_Public | 1 |
| Recruitment arrangements (for publication) | K2_M23-123_ES_Recruitment Poster 4_Public | 1 |
| Recruitment arrangements (for publication) | K2_M23-123_ES_Recruitment Poster 5_Public | 1 |
| Recruitment arrangements (for publication) | K2_M23-123_ES_Recruitment Poster 6_Public | 1 |
| Recruitment arrangements (for publication) | M23-123 BE Recruitment and ICF procedures public | 1.0 |
| Recruitment arrangements (for publication) | M23-123 BE Recruitment Material - Digital Ads public | 2.0 |
| Recruitment arrangements (for publication) | M23-123 BE Recruitment Material - Digital Ads public | 2.0 |
| Recruitment arrangements (for publication) | M23-123 BE Recruitment Material - Digital Ads public | 2.0 |
| Recruitment arrangements (for publication) | M23-123 BE Recruitment Material - Pt Messaging public | 2.0 |
| Recruitment arrangements (for publication) | M23-123 BE Recruitment Material - Pt Messaging public | 2.0 |
| Recruitment arrangements (for publication) | M23-123 BE Recruitment Material - Pt Messaging public | 2.0 |
| Recruitment arrangements (for publication) | M23-123 BE Recruitment Material - Recruitment Poster public | 2.0 |
| Recruitment arrangements (for publication) | M23-123 BE Recruitment Material - Recruitment Poster public | 2.0 |
| Recruitment arrangements (for publication) | M23-123 BE Recruitment Material - Recruitment Poster public | 2.0 |
| Recruitment arrangements (for publication) | M23-123 BE Recruitment Material - WS Prescreener public | 2.1 |
| Recruitment arrangements (for publication) | M23-123 BE Recruitment Material - WS Prescreener public | 2.1 |
| Recruitment arrangements (for publication) | M23-123 BE Recruitment Material - WS Prescreener public | 2.1 |
| Recruitment arrangements (for publication) | M23-123 BE Recruitment Material - WS Script public | 2.1 |
| Recruitment arrangements (for publication) | M23-123 BE Recruitment Material - WS Script public | 2.1 |
| Recruitment arrangements (for publication) | M23-123 BE Recruitment Material - WS Script public | 2.1 |
| Recruitment arrangements (for publication) | M23-123 BG Recruitment Material - Digital Ads Public | 2.0 |
| Recruitment arrangements (for publication) | M23-123 BG Recruitment Material - Pt Messaging Public | 2.0 |
| Recruitment arrangements (for publication) | M23-123 BG Recruitment Material - Recruitment Poster Public | 2.0 |
| Recruitment arrangements (for publication) | M23-123 BG Recruitment Material - WS Prescreener Public | 2.0 to 2.1 |
| Recruitment arrangements (for publication) | M23-123 BG Recruitment Material - WS Script Public | 2.1 |
| Recruitment arrangements (for publication) | M23-123 DE Recruitment and ICF Procedures public | 2.0 |
| Recruitment arrangements (for publication) | M23-123 DE Recruitment Material - Digital Ads public | 2.0 |
| Recruitment arrangements (for publication) | M23-123 DE Recruitment Material - Pt Messaging public | 2.0 |
| Recruitment arrangements (for publication) | M23-123 DE Recruitment Material - Recruitment Poster public | 2.0 |
| Recruitment arrangements (for publication) | M23-123 DE Recruitment Material - WS Prescreener public | 2.1 |
| Recruitment arrangements (for publication) | M23-123 DE Recruitment Material - WS Script public | 2.1 |
| Recruitment arrangements (for publication) | M23-123 ES Recruitment and ICF Procedures public | 1.1 |
| Recruitment arrangements (for publication) | M23-123 ES Recruitment Material - Digital Ads public | 2.0 |
| Recruitment arrangements (for publication) | M23-123 ES Recruitment Material - Pt Messaging public | 2.0 |
| Recruitment arrangements (for publication) | M23-123 ES Recruitment Material - Recruitment Poster public | 2.0 |
| Recruitment arrangements (for publication) | M23-123 ES Recruitment Material - Search Ads public | 1.1 |
| Recruitment arrangements (for publication) | M23-123 ES Recruitment Material - WS Prescreener public | 2.1 |
| Recruitment arrangements (for publication) | M23-123 ES Recruitment Material - WS Script public | 2.1 |
| Recruitment arrangements (for publication) | M23-123 FR Recruitment and ICF Procedures public | 1 |
| Recruitment arrangements (for publication) | M23-123 FR Recruitment Material - Digital Ads Public | 2.0 |
| Recruitment arrangements (for publication) | M23-123 FR Recruitment Material - Pt Messaging Public | 3.0 |
| Recruitment arrangements (for publication) | M23-123 FR Recruitment Material - Recruitment Poster Public | 2.0 |
| Recruitment arrangements (for publication) | M23-123 FR Recruitment Material - WS Prescreener Public | 3.1 |
| Recruitment arrangements (for publication) | M23-123 FR Recruitment Material - WS Script Public | 3.1 |
| Recruitment arrangements (for publication) | M23-123 IT Recruitment and ICF Procedures public | 1 |
| Recruitment arrangements (for publication) | M23-123 IT Recruitment Material - Digital Ads public | 2.0 |
| Recruitment arrangements (for publication) | M23-123 IT Recruitment Material - Pt Messaging public | 2.0 |
| Recruitment arrangements (for publication) | M23-123 IT Recruitment Material - Recruitment Poster public | 2.0 |
| Recruitment arrangements (for publication) | M23-123 IT Recruitment Material - WS Presceener public | 2.1 |
| Recruitment arrangements (for publication) | M23-123 IT Recruitment Material - WS Script public | 2.1 |
| Subject information and informed consent form (for publication) | L1 M23-123 - FR - Addendum ICF _Public | 1 |
| Subject information and informed consent form (for publication) | L1 M23-123 DE Informed Consent Main_Public | 4.0 |
| Subject information and informed consent form (for publication) | L1 M23-123 IT Main ICF_Public Redacted | 4 |
| Subject information and informed consent form (for publication) | L1 M23-123 IT Pregnant Privacy ICF Public | 1 |
| Subject information and informed consent form (for publication) | L1_M23-123 BE Main ICF Dutch Public | 7.0 |
| Subject information and informed consent form (for publication) | L1_M23-123 BE Main ICF English Public | 7.0 |
| Subject information and informed consent form (for publication) | L1_M23-123 BE Main ICF French Public | 7.0 |
| Subject information and informed consent form (for publication) | L1_M23-123 BG Informed Consent_Public Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_M23-123 BG Informed Consent_Public Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_M23-123 FR Main ICF_Public | 5.1 |
| Subject information and informed consent form (for publication) | L1_M23-123_ES_ ICF Main_Public | 5.0 |
| Summary of Product Characteristics (SmPC) (for publication) | botox 100U spc clean common_public | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | vistabel 50U 100U pil clean common_Public | 2 |
| Synopsis of the protocol (for publication) | M23-123 BE Protocol Synopsis Dutch public | 7.0 |
| Synopsis of the protocol (for publication) | M23-123 BG Protocol synopsis Bulgarian public | 7.0 |
| Synopsis of the protocol (for publication) | M23-123 DE Protocol Synopsis German public | 7.0 |
| Synopsis of the protocol (for publication) | M23-123 ES Protocol Synopsis Spanish public | 7.0 |
| Synopsis of the protocol (for publication) | M23-123 IT Protocol Synopsis Italian public | 7.0 |
| Synopsis of the protocol (for publication) | M23-123 Protocol Lay Summary Protocol Synopsis_English | 1 |
| Synopsis of the protocol (for publication) | M23-123 Protocol Lay Summary Synopsis_Dutch | 1 |
| Synopsis of the protocol (for publication) | M23-123 Protocol Lay Summary Synopsis_Dutch_Belgium | 1 |
| Synopsis of the protocol (for publication) | M23-123 Protocol Lay Summary Synopsis_French_Belgium | 1 |
| Synopsis of the protocol (for publication) | M23-123 Protocol Lay Summary Synopsis_German_Belgium | 1 |
| Synopsis of the protocol (for publication) | M23-123 protocol synopsis_Public | 7.0 |
| Synopsis of the protocol (for publication) | M23-123_Protocol Lay Summary-Synopsis_French | 1 |
| Synopsis of the protocol (for publication) | M23-123-FR-Protocol Synopsis_public | 7.0 |
Application history
8 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2022-10-04 | Germany | Acceptable 2023-02-06
|
2023-02-06 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-06-22 | Germany | Acceptable 2023-09-26
|
2023-09-27 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2023-12-13 | Germany | Acceptable 2024-02-28
|
2024-02-29 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-07-31 | Germany | Acceptable 2024-10-30
|
2024-10-30 |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-11-15 | Acceptable | 2024-12-10 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-02-04 | Acceptable | 2025-03-04 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-03-21 | Germany | Acceptable 2025-06-03
|
2025-06-04 |
| 8 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-11-20 | Acceptable 2025-06-03
|
2025-11-20 |