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

NCT ID: NCT04679142

Last Updated: 2021-01-05

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 975 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-12-22
• Study Completion Date: 2025-11-30

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.

Conditions

Alcohol Use Disorder

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Adult patients starting a treatment with Baclocur®

Baclofen(Baclocur®) 10mg, 20mg, 30mg, 40mg.

Baclofen Tablets

Intervention Type: DRUG

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.

Interventions

Baclofen Tablets

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.

Intervention Type: DRUG

Other Intervention Names

Baclocur®

Eligibility 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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ethypharm

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Henri-Jean Aubin, MD, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Hospital Paul Brousse Villejuif France

Locations

CHU Dijon

Dijon, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Olga Starchik, MD

Role: CONTACT

starchik.olga@ethypharm.com

+33626791157

Facility Contacts

Benôit Trojak, MD

Role: primary

Other Identifiers

ID-RCB: 2020-A00722-37

Identifier Type: OTHER

Identifier Source: secondary_id

ALP2011007/005

Identifier Type: -

Identifier Source: org_study_id