Baclocur® Post-Authorisation Safety Study in Real-life Settings in France

Recruiting

• Conditions: Alcohol Use Disorder
• Interventions: Drug: Baclofen Tablets

• Registration Number: NCT04679142
• Lead Sponsor: Ethypharm

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 patients will receive treatment and evaluations for their disease as determined by their physicians in accordance with local standard of care. Visits will be scheduled by their physician according to patient-specific needs and national clinical practice.

For purposes of this study, physicians will be requested to record information on enrolled patients at the time of study enrolment (baseline), and then to conduct follow-up patient visits based on their usual practice for a period of 12 months following Baclocur® initiation.

At study end, further investigations on patients confirmed as lost to follow-up (LFU) will be performed through the use of the French medico-administrative database called the Système National des Données de Santé (SNDS). The goal will be to determine their vital status and collect relevant treatment and safety data over the studied period to further assess the safety of Baclocur®. A probabilistic approach using relevant matching variables (e.g. gender, year of birth, date of Baclocur prescription, department of care) will be used to retrieve these SNDS data of interest.

The patient study enrolment period is expected to be approximately of 3 years. Accounting for the 12 months follow-up period per patient, the full study field duration is expected to be approximately of 4 years. One additional year will be needed before the SNDS matching is performed, taken into account the delay required for the SNDS to be updated. With the final analysis and final clinical study report, this will lead to a total study duration of approximately 6 years.

Study Timeline

• Study First Submitted: 2020-12-07
• Study First Submitted QC: 2020-12-17
• Study Start: 2020-12-22
• Study First Posted: 2020-12-22
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-04
• Last Update Posted: 2021-01-05
• Primary Completion: 2024-11
• Study Completion: 2025-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 975

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Adult patients starting a treatment with Baclocur®	Baclofen Tablets	Baclofen(Baclocur®) 10mg, 20mg, 30mg, 40mg.

Primary Outcome Measures

Name	Time	Method
Incidence of serious adverse events (SAE)	12-month follow-up period	To estimate the incidence of serious adverse events (SAE)

Secondary Outcome Measures

Name	Time	Method
Incidence of all adverse events over the 12-month follow-up	12-month follow-up period	Incidence of all adverse events

Trial Locations

Locations (1)

CHU Dijon; 🇫🇷 Dijon, France