Baclocur® Post-Authorisation Safety Study in Real-life Settings in France
BACLOLIFE
2 other identifiers
observational
975
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2020
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 7, 2020
CompletedFirst Posted
Study publicly available on registry
December 22, 2020
CompletedStudy Start
First participant enrolled
December 22, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2025
CompletedJanuary 5, 2021
January 1, 2021
3.9 years
December 7, 2020
January 4, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of serious adverse events (SAE)
To estimate the incidence of serious adverse events (SAE)
12-month follow-up period
Secondary Outcomes (1)
Incidence of all adverse events over the 12-month follow-up
12-month follow-up period
Study Arms (1)
Adult patients starting a treatment with Baclocur®
Baclofen(Baclocur®) 10mg, 20mg, 30mg, 40mg.
Interventions
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.
Eligibility Criteria
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.
You may qualify if:
- Patient aged 18 or more;
- Initiating a treatment with Baclocur®;
- Informed and having agreed to participate in the study;
- Covered by healthcare insurance.
You may not qualify if:
- Current participation in a clinical trial;
- Previous treatment with baclofen/Baclocur®;
- Patient deprived of liberty by a judicial or administrative decision, or who is under a measure of legal protection (e.g. guardianship or curatorship).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ethypharmlead
Study Sites (1)
CHU Dijon
Dijon, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Henri-Jean Aubin, MD, Ph.D
Hospital Paul Brousse Villejuif France
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 7, 2020
First Posted
December 22, 2020
Study Start
December 22, 2020
Primary Completion
November 1, 2024
Study Completion
November 1, 2025
Last Updated
January 5, 2021
Record last verified: 2021-01