Efficacy and Safety on SOM3355 in Huntington's Disease Chorea

August 27, 2025 updated by: SOM Innovation Biotech SA

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

139

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Angers, France
        • Centre Hospitalier Universitaire Angers
      • Créteil, France
        • CHU Hôpital Henri Mondor (APHP)
      • Lille, France
        • Hopital Roger Salengro - CHU Lille
      • Strasbourg, France
        • Hôpital de Hautepierre
      • Toulouse, France
        • Hopital PURPAN - CHU TOULOUSE
  • Germany
      • Berlin, Germany
        • Charite - Universitätsmedizin Berlin
      • Münster, Germany
        • George Huntington Institut
      • Taufkirchen, Germany
        • Kbo-Isar-Amper-Klinikum Taufkirchen
      • Ulm, Germany
        • Hospital of University of Ulm
  • Italy
      • Bologna, Italy
        • IRCCS Istituto delle Scienze Neurologiche di Bologna
      • Napoli, Italy
        • Azienda Ospedaliera Universitaria Federico II
      • Roma, Italy
        • IRCCS Casa Sollievo della Sofferenza
      • Roma, Italy
        • Sant'Andrea University Hospital
  • Poland
      • Krakow, Poland
        • Krakowska Akademia Neurologii Sp. z o.o.
      • Poznan, Poland
        • Indywidualna Praktyka Lekarska Daniel Zielonka
  • Spain
      • Barcelona, Spain
        • Hospital De La Santa Creu I Sant Pau
      • Bilbao, Spain
        • Hospital Universitario de Cruces
      • Burgos, Spain
        • Hospital Universitario de Burgos
      • Madrid, Spain
        • Hospital Ramon y Cajal
  • Switzerland
      • Bern, Switzerland
        • Universitaetsspital Bern - Inselspital
  • United Kingdom
      • Cambridge, United Kingdom
        • Cambridge University Hospitals NHS Foundation Trust Addenbrooke's Hospital
      • Manchester, United Kingdom
        • NIHR Wellcome Trust Manchester Clinical Research Facility
      • Oxford, United Kingdom
        • Oxford University Hospitals NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria: Males or females ≥21 years old, a diagnosis of Huntington's Disease determined by a movement disorders expert and confirmed by a number of HTT gene CAG repeats ≥36, a UHDRS® Total maximal chorea (TMC) score ≥10, and a UHDRS® Total Functional Capacity (TFC) ≥7.

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Placebo capsules were administered twice daily (BID) for at least 9 weeks at maintenance dose.
Drug: Placebo capsules
Treatment was blind for the whole duration of the study.
Experimental: SOM3355 400 mg/day
SOM3355 200 mg capsules were administered twice daily (BID) for at least 9 weeks at maintenance dose.
Drug: SOM3355 200 mg capsules
Treatment was blind for the whole duration of the study.
Other Names:
  • Bevantolol hydrochloride
Experimental: SOM3355 600 mg/day
SOM3355 300 mg capsules were administered twice daily (BID) for at least 8 weeks at maintenance dose.
Drug: SOM3355 300 mg capsules
Treatment was blind for the whole duration of the study.
Other Names:
  • Bevantolol hydrochloride

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Total Maximal Chorea (TMC) Score of the UHDRS® for Subjects Not Taking Neuroleptics During the Trial (mITT - N=122)
Time Frame: From baseline to end of maintenance dose (10 weeks of treatment).

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the Clinical Global Impression (CGI) (mITT - N=139)
Time Frame: From baseline to end of maintenance dose (10 weeks of treatment).
The key secondary endpoint was the Clinical Global Impression of Change (CGI-C) at Visit 5 (week 10). The key secondary efficacy analysis was conducted on the mITT Population, including 139 subjects. Subjects with a score of 1 (Very much improved), 2 (Much improved), or 3 (Minimally improved) were defined as "Improved", and patients with a score of 4 (No change), 5 (Worse), 6 (Much worse), and 7 (Very much worse) were defined as "Not Improved".
From baseline to end of maintenance dose (10 weeks of treatment).
Change in the Patient Global Impression (PGI) (mITT - N=139)
Time Frame: From baseline to end of maintenance dose (10 weeks of treatment).
Another relevant secondary endpoint was the Patient Global Impression of Change (PGI-C) at Visit 5 (week 10). The efficacy analysis was conducted on the mITT Population, including 139 subjects. Subjects with a score of 1 (Very much improved), 2 (Much improved), or 3 (Minimally improved) were defined as "Improved", and patients with a score of 4 (No change), 5 (Worse), 6 (Much worse), and 7 (Very much worse) were defined as "Not Improved".
From baseline to end of maintenance dose (10 weeks of treatment).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SOM Innovation Biotech SA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 2, 2022

Primary Completion (Actual)

June 25, 2024

Study Completion (Actual)

July 15, 2024

Study Registration Dates

First Submitted

July 22, 2022

First Submitted That Met QC Criteria

July 26, 2022

First Posted (Actual)

July 27, 2022

Study Record Updates

Last Update Posted (Estimated)

August 28, 2025

Last Update Submitted That Met QC Criteria

August 27, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SOMCT03
  • 2021-003453-28 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Huntington Chorea

Clinical Trials on Placebo capsules

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in New Zealand

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe