Trials / Completed
CompletedNCT01738282
Efficacy and Safety of Baclofen for Maintenance of Abstinence in Alcohol Dependent Patients
A Randomized, Multicentric, Double Blind Study to Assess the Efficacy of Xylka® (Baclofen) at the Target Dosage of 180mg/Day Compared to Placebo, for Maintenance of Abstinence in Alcohol Dependent Patients
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 316 (estimated)
- Sponsor
- Ethypharm · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of the study is to assess the efficacy of Xylka® (baclofen) compared to placebo on continuous abstinence rate during 20 weeks of treatment, after withdrawal, in alcohol dependent patients receiving Brenda therapy sessions.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Baclofen | |
| DRUG | Placebo (for baclofen) |
Timeline
- Start date
- 2012-12-01
- Primary completion
- 2014-07-01
- Completion
- 2014-07-01
- First posted
- 2012-11-30
- Last updated
- 2014-07-30
Locations
38 sites across 1 country: France
Source: ClinicalTrials.gov record NCT01738282. Inclusion in this directory is not an endorsement.