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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04679142
Recruitment Status : Recruiting
First Posted : December 22, 2020
Last Update Posted : January 5, 2021
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Alcohol Use Disorder 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.

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Study Type : Observational
Estimated Enrollment : 975 participants
Observational Model: Other
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

Drug Information available for: Baclofen

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 Name: Baclocur®




Primary Outcome Measures :
  1. Incidence of serious adverse events (SAE) [ Time Frame: 12-month follow-up period ]
    To estimate the incidence of serious adverse events (SAE)


Secondary Outcome Measures :
  1. Incidence of all adverse events over the 12-month follow-up [ Time Frame: 12-month follow-up period ]
    Incidence of all adverse events



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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).

Information from the National Library of Medicine

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


Contacts
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Contact: Olga Starchik, MD +33626791157 starchik.olga@ethypharm.com

Locations
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France
CHU Dijon Recruiting
Dijon, France
Contact: Benôit Trojak, MD         
Sponsors and Collaborators
Ethypharm
Investigators
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Principal Investigator: Henri-Jean Aubin, MD, Ph.D Hospital Paul Brousse Villejuif France
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Responsible Party: Ethypharm
ClinicalTrials.gov Identifier: NCT04679142    
Other Study ID Numbers: ALP2011007/005
ID-RCB: 2020-A00722-37 ( Other Identifier: ANSM FRANCE )
First Posted: December 22, 2020    Key Record Dates
Last Update Posted: January 5, 2021
Last Verified: January 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Baclofen
Muscle Relaxants, Central
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents
GABA-B Receptor Agonists
GABA Agonists
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action