Safety assessment of Baclocur® for alcohol use disorder in France
Baclocur® Post-Authorisation Safety Study in Real-life Settings in France
This study is testing how safe Baclocur® is for people with alcohol use disorder in France over a year of treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 975 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ethypharm Industry-sponsored |
| Locations | 1 site (Dijon) |
| Trial ID | NCT04679142 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the safety profile and risks associated with Baclocur® in real-life settings over a 12-month follow-up period. It is a multicenter, non-comparative, non-interventional post-authorisation safety study conducted in France, where enrolled patients will receive treatment as determined by their physicians according to standard care practices. Physicians will record patient information at baseline and conduct follow-up visits based on individual patient needs. Additionally, data on patients lost to follow-up will be retrieved from a national health database to assess their vital status and treatment outcomes.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older who are initiating treatment with Baclocur® and are covered by healthcare insurance.
Not a fit: Patients currently participating in another clinical trial or those with prior treatment using baclofen/Baclocur® may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the safety and effectiveness of Baclocur® for patients with alcohol use disorder.
How similar studies have performed: Other studies have shown varying degrees of success in assessing the safety of medications for alcohol use disorder, but this specific approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patient aged 18 or more; 2. Initiating a treatment with Baclocur®; 3. Informed and having agreed to participate in the study; 4. Covered by healthcare insurance. Exclusion Criteria: 1. Current participation in a clinical trial; 2. Previous treatment with baclofen/Baclocur®; 3. Patient deprived of liberty by a judicial or administrative decision, or who is under a measure of legal protection (e.g. guardianship or curatorship).
Where this trial is running
Dijon
- CHU Dijon — Dijon, France (Recruiting)
Study contacts
- Principal investigator: Henri-Jean Aubin, MD, Ph.D — Hospital Paul Brousse Villejuif France
- Study coordinator: Olga Starchik, MD
- Email: starchik.olga@ethypharm.com
- Phone: +33626791157
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.