Conditions: Huntington's Disease
Keywords: Huntington's Disease
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 437
Healthy volunteers: no

Brief summary:
The purpose of this study is to determine if ACR16 is effective and safe in the symptomatic treatment of Huntington's disease.

Detailed description:
The primary objective in the present study is to confirm whether ACR16 is efficacious in improving voluntary motor function in Huntington's disease based on the Unified Huntington"s Disease Rating Scale (UHDRS) subscale. These symptoms seem to be most important for the functional disability associated with the disorder. To achieve this, participants are randomized to ACR16 45 mg once daily, ACR16 45 mg twice daily, or placebo treatment in equal proportions in a parallel design for a treatment duration of 26 weeks.

Arms:
arm 1: Participants will receive a placebo capsule matching to ACR16 once daily for the first 4 weeks. After 4 weeks (Weeks 5 to 26), placebo capsule will be taken twice daily as 2 separate doses. arm 2: Participants will receive ACR16 45 milligrams (mg) capsule orally once daily for the first 4 weeks. After 4 weeks (Weeks 5 to 26), one ACR16 45 mg capsule and one placebo capsule will be taken as 2 separate doses. arm 3: Participants will receive ACR16 45 mg capsule once daily for the first 4 weeks. After 4 weeks (Weeks 5 to 26), ACR16 45 mg capsule will be taken twice daily as 2 separate doses (total dose: 90 mg)

Interventions: intervention 1: ACR16 intervention 2: Placebo
Intervention descriptions: intervention 1: Capsules will be swallowed whole with water. intervention 2: Capsules will be swallowed whole with water.

Protocol document: