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Efficacy and Safety on SOM3355 in Huntington's Disease Chorea

NCT05475483 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 139

Last updated 2025-08-28

Study results available
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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.

Conditions

  • Huntington Chorea

Interventions

DRUG

Placebo capsules

Treatment was blind for the whole duration of the study.

DRUG

SOM3355 200 mg capsules

Treatment was blind for the whole duration of the study.

DRUG

SOM3355 300 mg capsules

Treatment was blind for the whole duration of the study.

Sponsors & Collaborators

  • SOM Innovation Biotech SA

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-02
Primary Completion
2024-06-25
Completion
2024-07-15

Countries

  • France
  • Germany
  • Italy
  • Poland
  • Spain
  • Switzerland
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05475483 on ClinicalTrials.gov