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

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.

Study Overview

• Status: Recruiting
• Conditions: Alcohol Use Disorder
• Intervention / Treatment: Drug: Baclofen Tablets

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 Type: Observational
• Enrollment (Anticipated): 975

Contacts and Locations

• Study Contact: Name: Olga Starchik, MD; Phone Number: +33626791157; Email: starchik.olga@ethypharm.com

Study Locations

• France
  • Dijon, France
    • Recruiting
    • CHU Dijon
    • Contact: Benoit Trojak, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Adult patients starting a treatment with Baclocur®. Patients having already taken Baclocur®/baclofen in the past are not eligible; only treatment-naïve patients are eligible.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Adult patients starting a treatment with Baclocur®; Baclofen(Baclocur®) 10mg, 20mg, 30mg, 40mg.	Drug: 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.; Other Names: Baclocur®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of serious adverse events (SAE)	To estimate the incidence of serious adverse events (SAE)	12-month follow-up period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of all adverse events over the 12-month follow-up	Incidence of all adverse events	12-month follow-up period

Collaborators and Investigators

• Sponsor: Ethypharm
• Investigators: Principal Investigator: Henri-Jean Aubin, MD, Ph.D, Hospital Paul Brousse Villejuif France

Study record dates

Study Major Dates

• Study Start (Actual): December 22, 2020
• Primary Completion (Anticipated): November 1, 2024
• Study Completion (Anticipated): November 1, 2025

Study Registration Dates

• First Submitted: December 7, 2020
• First Submitted That Met QC Criteria: December 17, 2020
• First Posted (Actual): December 22, 2020

Study Record Updates

• Last Update Posted (Actual): January 5, 2021
• Last Update Submitted That Met QC Criteria: January 4, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Alcoholism; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; GABA Agents; Neuromuscular Agents; Muscle Relaxants, Central; GABA Agonists; GABA-B Receptor Agonists; Baclofen
• Other Study ID Numbers: ALP2011007/005; ID-RCB: 2020-A00722-37 (Other Identifier: ANSM FRANCE)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No