Status:
UNKNOWN
Baclocur® Post-Authorisation Safety Study in Real-life Settings in France
Lead Sponsor:
Ethypharm
Conditions:
Alcohol Use Disorder
Eligibility:
All Genders
18+ years
Brief Summary
The overall goal of the study is to further characterize the risks and the safety profile of Baclocur® in real life settings, over a 12-month follow-up period.
Detailed Description
This is a prospective, multicenter, non-comparative non-interventional post-authorisation safety study (PASS) conducted in France. There will be no experimental intervention utilized. Enrolled patient...
Eligibility Criteria
Inclusion
- Patient aged 18 or more;
- Initiating a treatment with Baclocur®;
- Informed and having agreed to participate in the study;
- Covered by healthcare insurance.
Exclusion
- Current participation in a clinical trial;
- Previous treatment with baclofen/Baclocur®;
- Patient deprived of liberty by a judicial or administrative decision, or who is under a measure of legal protection (e.g. guardianship or curatorship).
Key Trial Info
Start Date :
December 22 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
November 1 2025
Estimated Enrollment :
975 Patients enrolled
Trial Details
Trial ID
NCT04679142
Start Date
December 22 2020
End Date
November 1 2025
Last Update
January 5 2021
Active Locations (1)
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1
CHU Dijon
Dijon, France