Efficacy and Safety on SOM3355 in Huntington's Disease Chorea

• Register: ClinicalTrials.gov
• Last refreshed on: 30 September 2024
• Main ID: NCT05475483
• Date of registration: 22/07/2022
• Prospective Registration: Yes
• Primary sponsor: SOM Innovation Biotech SA
• Public title: Efficacy and Safety on SOM3355 in Huntington's Disease Chorea
• Scientific 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
• Date of first enrolment: August 2, 2022
• Target sample size: 140
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT05475483
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

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

Key inclusion & exclusion 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.


Age minimum: 21 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Huntington Chorea

Intervention(s)

Drug: Placebo capsules

Drug: SOM3355 capsules

Primary Outcome(s)

Change in Total Maximal Chorea (TMC) score of the UHDRS® [Time Frame: Between baseline and end of maintenance dose (after 10 weeks of treatment)]

Secondary Outcome(s)

Change in the Total Motor Score (TMS) of the UHDRS® [Time Frame: Between baseline and end of maintenance dose (after 10 weeks of treatment)]

TMC-response defined as improvement =2 in TMC score [Time Frame: Between baseline and end of maintenance dose (after 10 weeks of treatment)]

Change in the Dystonia sub-score of the UHDRS® [Time Frame: Between baseline and end of maintenance dose (after 10 weeks of treatment)]

Change in the Gait sub-score of the UHDRS® [Time Frame: Between baseline and end of maintenance dose (after 10 weeks of treatment)]

Change in the European Quality of Life scale (EQ-5D-5L) [Time Frame: Between baseline and end of maintenance dose (after 10 weeks of treatment)]

Percentage of change in TMC score [Time Frame: Between baseline and end of maintenance dose (after 10 weeks of treatment)]

Change in the Clinical Global Impression (CGI) [Time Frame: Between baseline and end of maintenance dose (after 10 weeks of treatment)]

Change in the Patient Global Impression (PGI) [Time Frame: Between baseline and end of maintenance dose (after 10 weeks of treatment)]

Secondary ID(s)

2021-003453-28

SOMCT03

Source(s) of Monetary Support

Please refer to primary and secondary sponsors