Baclocur® Post-Authorisation Safety Study in Real-life Settings in France (BACLOLIFE)
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|ClinicalTrials.gov Identifier: NCT04679142|
Recruitment Status : Recruiting
First Posted : December 22, 2020
Last Update Posted : January 5, 2021
|Condition or disease||Intervention/treatment|
|Alcohol Use Disorder||Drug: Baclofen Tablets|
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|
|Estimated Enrollment :||975 participants|
|Official Title:||Baclocur® Post-Authorisation Safety Study in Real-life Settings in France|
|Actual Study Start Date :||December 22, 2020|
|Estimated Primary Completion Date :||November 2024|
|Estimated Study Completion Date :||November 2025|
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 Name: Baclocur®
- Incidence of serious adverse events (SAE) [ Time Frame: 12-month follow-up period ]To estimate the incidence of serious adverse events (SAE)
- Incidence of all adverse events over the 12-month follow-up [ Time Frame: 12-month follow-up period ]Incidence of all adverse events
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04679142
|Contact: Olga Starchik, MDemail@example.com|
|Contact: Benôit Trojak, MD|
|Principal Investigator:||Henri-Jean Aubin, MD, Ph.D||Hospital Paul Brousse Villejuif France|