Efficacy and Safety on SOM3355 in Huntington's Disease Chorea
Phase IIb, Randomized, Double-blind, Placebo-controlled Study in Parallel Groups Assessing the Efficacy and Safety of Two Doses of SOM3355 in Patients Suffering From Huntington's Disease With Choreic Movements
2 other identifiers
interventional
139
7 countries
23
Brief Summary
Phase IIb, randomized, double-blind, placebo-controlled study in parallel groups assessing the efficacy and safety of two doses of SOM3355 in patients suffering from Huntington's Disease with choreic movements.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Aug 2022
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 22, 2022
CompletedFirst Posted
Study publicly available on registry
July 27, 2022
CompletedStudy Start
First participant enrolled
August 2, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 25, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
July 15, 2024
CompletedResults Posted
Study results publicly available
August 28, 2025
CompletedAugust 28, 2025
August 1, 2025
1.9 years
July 22, 2022
July 9, 2025
August 27, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Total Maximal Chorea (TMC) Score of the UHDRS® for Subjects Not Taking Neuroleptics During the Trial (mITT - N=122)
Pre-defined analysis of the primary efficacy endpoint (change in TMC score from baseline to the end of maintenance dose) performed with the 122 subjects of the mITT not taking neuroleptics during the trial. The TMC is part of the motor assessment of the Unified Huntington's Disease Rating Scale (UHDRS) and measures chorea in 7 different body parts, including the face, oral-buccal-lingual region, trunk, and each limb independently. The TMC score is the sum of the individual scores, ranging from 0 to 28. A decrease in TMC scores indicates improvement in chorea symptoms.
From baseline to end of maintenance dose (10 weeks of treatment).
Secondary Outcomes (2)
Change in the Clinical Global Impression (CGI) (mITT - N=139)
From baseline to end of maintenance dose (10 weeks of treatment).
Change in the Patient Global Impression (PGI) (mITT - N=139)
From baseline to end of maintenance dose (10 weeks of treatment).
Study Arms (3)
Placebo
PLACEBO COMPARATORPlacebo capsules were administered twice daily (BID) for at least 9 weeks at maintenance dose.
SOM3355 400 mg/day
EXPERIMENTALSOM3355 200 mg capsules were administered twice daily (BID) for at least 9 weeks at maintenance dose.
SOM3355 600 mg/day
EXPERIMENTALSOM3355 300 mg capsules were administered twice daily (BID) for at least 8 weeks at maintenance dose.
Interventions
Treatment was blind for the whole duration of the study.
Treatment was blind for the whole duration of the study.
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (23)
Centre Hospitalier Universitaire Angers
Angers, France
CHU Hôpital Henri Mondor (APHP)
Créteil, France
Hôpital Roger Salengro - CHU Lille
Lille, France
Hopital de Hautepierre
Strasbourg, France
Hôpital Purpan - CHU Toulouse
Toulouse, France
Charité - Universitätsmedizin Berlin
Berlin, Germany
George Huntington Institut
Münster, Germany
Kbo-Isar-Amper-Klinikum Taufkirchen
Taufkirchen, Germany
Hospital of University of Ulm
Ulm, Germany
IRCCS Istituto delle Scienze Neurologiche di Bologna
Bologna, Italy
Azienda Ospedaliera Universitaria Federico II
Napoli, Italy
IRCCS Casa Sollievo della Sofferenza
Roma, Italy
Sant'Andrea University Hospital
Roma, Italy
Krakowska Akademia Neurologii Sp. z o.o.
Krakow, Poland
Indywidualna Praktyka Lekarska Daniel Zielonka
Poznan, Poland
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain
Hospital Universitario de Cruces
Bilbao, Spain
Hospital Universitario de Burgos
Burgos, Spain
Hospital Ramón y Cajal
Madrid, Spain
Universitaetsspital Bern - Inselspital
Bern, Switzerland
Cambridge University Hospitals NHS Foundation Trust Addenbrooke's Hospital
Cambridge, United Kingdom
NIHR Wellcome Trust Manchester Clinical Research Facility
Manchester, United Kingdom
Oxford University Hospitals NHS Foundation Trust
Oxford, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- SOM Innovation Biotech SA
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 22, 2022
First Posted
July 27, 2022
Study Start
August 2, 2022
Primary Completion
June 25, 2024
Study Completion
July 15, 2024
Last Updated
August 28, 2025
Results First Posted
August 28, 2025
Record last verified: 2025-08