Efficacy and Safety on SOM3355 in Huntington's Disease Chorea

SOM Biotech

Status and phase: Completed; Phase 2

Conditions: Huntington Chorea

Treatments: Drug: SOM3355 300 mg capsules; Drug: SOM3355 200 mg capsules; Drug: Placebo capsules

Study type: Interventional

Funder types: Industry

Identifiers

NCT05475483

2021-003453-28 (EudraCT Number)

SOMCT03

Details and patient eligibility

About

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.

Enrollment: 139 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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139 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo capsules were administered twice daily (BID) for at least 9 weeks at maintenance dose.

Treatment:

Drug: Placebo capsules

SOM3355 400 mg/day

Experimental group

Description:

SOM3355 200 mg capsules were administered twice daily (BID) for at least 9 weeks at maintenance dose.

Treatment:

Drug: SOM3355 200 mg capsules

SOM3355 600 mg/day

Experimental group

Description:

SOM3355 300 mg capsules were administered twice daily (BID) for at least 8 weeks at maintenance dose.

Treatment:

Drug: SOM3355 300 mg capsules