Efficacy and Safety on SOM3355 in Huntington’s Disease Chorea

Brief Title

Efficacy and Safety on SOM3355 in Huntington's Disease Chorea

Official Title

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

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.
    

Study Phase

Phase 2

Study Type

Interventional

Primary Outcome

Change in Total Maximal Chorea (TMC) score of the UHDRS®

Secondary Outcome

 Change in the Clinical Global Impression (CGI)

Condition

Huntington Chorea

Intervention

SOM3355 capsules

Study Arms / Comparison Groups

 SOM3355 300 mg BID

Description:  Administration of SOM3355 in up-titration for 3 weeks up to the maintenance dose of 300 mg BID (twice daily) administered for 7 additional weeks, and down-titration for 2 weeks.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Drug

Estimated Enrollment

129

Start Date

August 2022

Completion Date

June 2023

Primary Completion Date

March 2023

Eligibility Criteria

        Inclusion Criteria:

          1. Males or females ≥21 years old.

          2. Patients with a diagnosis of Huntington's Disease determined by a movement disorders
             expert and confirmed by a number of HTT gene CAG repeats ≥36.

          3. UHDRS® Total maximal chorea (TMC) score ≥10.

          4. UHDRS® Total Functional Capacity (TFC) ≥7.

          5. Able to walk independently or with minimal assistance.

          6. Females of child-bearing potential must use a medically accepted effective method of
             birth control and should not be breast-feeding.

          7. In the opinion of the Investigator, the patient must have adequate support to comply
             with the entire study requirements.

          8. Able and willing to provide written informed consent.

        Exclusion Criteria:

          1. Onset of HD symptoms prior to age of 21 years (juvenile forms of HD).

          2. HD patients presenting rigid akinesia.

          3. Use of other VMAT2 inhibitors such as tetrabenazine, deutetrabenazine, or valbenazine;
             and use of other antichoreic treatment such as any neuroleptic, or amantadine,
             memantine, riluzole.

          4. Patients who experienced severe depression or suicide attempt in the last 5 years.

          5. Severe untreated or under-treated psychiatric illness such as active suicidal ideation
             or behavior or depression.

          6. Patients with a history of, or current, hypotension, bradycardia, or orthostatic
             hypotension.

          7. Patients with hypertension already treated with more than 2 antihypertensive drugs.

          8. Other active clinically significant illness, which could interfere with the study
             conduct, counter-indicate the study treatment, place the patient at risk during the
             trial, or compromise their study participation.

          9. Any significant serious abnormality in the electrocardiogram (ECG), or a known history
             of long QTc syndrome.

         10. Patients with severe hepatic impairment, or with severe renal impairment, or with any
             other significant abnormality in the physical examination or clinical laboratory
             results that, in the Investigator's opinion, would not be compatible with study
             participation or represent a risk for the patient while in the study.

         11. Females who are pregnant or lactating, or who intend to become pregnant during the
             study period.

         12. Patients with allergy under desensitization, with known psoriasis, or a known
             allergy/hypersensitivity to any ingredients of the trial medication or placebo.

         13. History of alcohol or substance abuse in the previous 12 months.

         14. Patients participating in any other study, and the use of any investigational therapy.
      

Gender

All

Ages

21 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, 934020150, [email protected]

Location Countries

France

Location Countries

France

NCT ID

NCT05475483

Organization ID

SOMCT03

Secondary IDs

2021-003453-28

Responsible Party

Sponsor

Study Sponsor

SOM Innovation Biotech SA

Study Sponsor

, , 

Verification Date

July 2022