Trials / Completed
CompletedNCT00665223
A Study of Treatment With Pridopidine (ACR16) in Participants With Huntington's Disease
A Multicentre, Multinational, Randomised, Double-Blind, Parallel-Group Study Comparing ACR16 45 mg Once-Daily or Twice-Daily Versus Placebo for the Symptomatic Treatment of Huntington's Disease
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 437 (actual)
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc. · Industry
- Sex
- All
- Age
- 30 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ACR16 | Capsules will be swallowed whole with water. |
| DRUG | Placebo | Capsules will be swallowed whole with water. |
Timeline
- Start date
- 2008-04-24
- Primary completion
- 2010-06-14
- Completion
- 2010-06-14
- First posted
- 2008-04-23
- Last updated
- 2023-08-29
- Results posted
- 2023-08-29
Locations
31 sites across 8 countries: Austria, Belgium, France, Germany, Italy, Portugal, Spain, United Kingdom
Source: ClinicalTrials.gov record NCT00665223. Inclusion in this directory is not an endorsement.