CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 139 enrolled
Drug / intervention
Placebo capsules +2 moredrug
Likely dose
SOM3355 200 mg or 300 mg orallyAI-extracted
Key inclusion· 5
  • ✓Age ≥21 years
  • ✓Huntington's disease diagnosed by movement disorders expert
  • ✓HTT gene CAG repeats ≥36 (confirmed genetic diagnosis)
  • ✓UHDRS Total Maximal Chorea (TMC) score ≥10
Key exclusion· 4
  • ✕Symptom onset before age 21 (juvenile-onset Huntington's disease)
  • ✕Rigid-akinetic phenotype
  • ✕Current or recent VMAT2 inhibitors (tetrabenazine, deutetrabenazine, valbenazine)
  • ✕Current or recent antichoreic treatment: neuroleptics, amantadine, memantine, riluzole

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05475483
NCT05475483Phase 2Completed
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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

SOM Innovation Biotech SA·interventional·Posted Jul 27, 2022·Updated Aug 28, 2025

In Brief

A Phase 2 clinical trial evaluating Placebo capsules, SOM3355 200 mg capsules, and 1 other intervention for Huntington Chorea. Completed, enrolled 139 participants across 23 sites in 7 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHuntington Chorea
CountriesFrance, Germany, Italy, Poland, Spain, Switzerland, United Kingdom
Collaborators--

Timeline

Phase 2CompletedFinished
2023202420252026
First PostedJul 27, 2022
Enrollment StartAug 2, 2022
Primary CompletionJun 25, 2024
Study CompletionJul 15, 2024
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 3.9 years ago

Interventions

Placebo capsulesdrug

Treatment was blind for the whole duration of the study.

SOM3355 200 mg capsulesdrug

Treatment was blind for the whole duration of the study.

SOM3355 300 mg capsulesdrug

Treatment was blind for the whole duration of the study.