Efficacy and Safety on SOM3355 in Huntington's Disease Chorea
NCT ID: NCT05475483
Last Updated: 2025-08-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
139 participants
INTERVENTIONAL
2022-08-02
2024-07-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Placebo capsules were administered twice daily (BID) for at least 9 weeks at maintenance dose.
Placebo capsules
Treatment was blind for the whole duration of the study.
SOM3355 400 mg/day
SOM3355 200 mg capsules were administered twice daily (BID) for at least 9 weeks at maintenance dose.
SOM3355 200 mg capsules
Treatment was blind for the whole duration of the study.
SOM3355 600 mg/day
SOM3355 300 mg capsules were administered twice daily (BID) for at least 8 weeks at maintenance dose.
SOM3355 300 mg capsules
Treatment was blind for the whole duration of the study.
Interventions
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Placebo capsules
Treatment was blind for the whole duration of the study.
SOM3355 200 mg capsules
Treatment was blind for the whole duration of the study.
SOM3355 300 mg capsules
Treatment was blind for the whole duration of the study.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria: Onset of HD symptoms prior to age of 21 years (juvenile forms of HD), HD patients presenting rigid akinesia, and use of other VMAT2 inhibitors such as tetrabenazine, deutetrabenazine, or valbenazine, or other antichoreic treatment such as any neuroleptic, or amantadine, memantine, riluzole.
21 Years
ALL
No
Sponsors
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SOM Innovation Biotech SA
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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SOM Biotech website
Other Identifiers
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2021-003453-28
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
SOMCT03
Identifier Type: -
Identifier Source: org_study_id
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