Clinical trial NCT04679142: Baclocur® Post-Authorisation Safety Study in Real-life Settings in France
Official title: Baclocur® Post-Authorisation Safety Study in Real-life Settings in France
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Alcohol Use Disorder
Lead sponsor: Ethypharm
Sponsor class: INDUSTRY
First posted: 2020-12-22
Enrollment: 975
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.

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).

Primary outcomes:
measure: Incidence of serious adverse events (SAE)
timeFrame: 12-month follow-up period
Secondary outcomes:
measure: Incidence of all adverse events over the 12-month follow-up
timeFrame: 12-month follow-up period
Other outcomes:
Locations:
city: Dijon
country: France
facility: CHU Dijon
Study officials:
affiliation: Hospital Paul Brousse Villejuif France
name: Henri-Jean Aubin, MD, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: