Alcohol Use DisorderBACLOLIFENCT04679142
Baclocur® Post-Authorisation Safety Study in Real-life Settings in France
An observational study of Alcohol Use Disorder, run by Ethypharm at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcohol Use Disorder
- What is being tested?
- Baclofen Tablets
- Type of treatment
- Pill or oral medicine
- How many people
- 975 participants
- Where
- 1 siteFrance
- Study dates
- 22 Dec 2020to Nov 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Patient aged 18 or more;
- Initiating a treatment with Baclocur®;
- Informed and having agreed to participate in the study;
- Covered by healthcare insurance.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Alcohol Use Disorder
- Being tested
- Baclofen Tablets
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baclofen TabletsDrug
Also called Baclocur®
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.
| Study group | Role | What they receive |
|---|---|---|
| Adult patients starting a treatment with Baclocur® | Baclofen(Baclocur®) 10mg, 20mg, 30mg, 40mg. Receives: Drug: Baclofen Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of serious adverse events (SAE)
To estimate the incidence of serious adverse events (SAE)
Measured: 12-month follow-up period
Secondary outcomes (1)
Incidence of all adverse events over the 12-month follow-up
Incidence of all adverse events
Measured: 12-month follow-up period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2020
- Study start22 Dec 2020
- Primary completionNov 2024 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 975 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ethypharm
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Henri-Jean Aubin, MD, Ph.D, Principal investigator, Hospital Paul Brousse Villejuif France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04679142
- Sponsor's protocol ID
- ALP2011007/005
- Other IDs
- ID-RCB: 2020-A00722-37
- Acronym
- BACLOLIFE
- Status last verified
- Jan 2021
- First submitted
- 7 Dec 2020
- Last updated
- 5 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Baclocur® Post-Authorisation Safety Study in Real-life Settings in France
- ClinicalTrials.gov ID
- NCT04679142
- Acronym / sponsor ID
- BACLOLIFE / ALP2011007/005
- Conditions
- Alcohol Use Disorder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 975 participants (estimated)
- Lead sponsor
- EthypharmIndustry (pharma, biotech, devices)
- Study start
- 22 Dec 2020 (actual)
- Primary completion
- Nov 2024 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 22 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult patients starting a treatment with Baclocur® | – | Drug: Baclofen TabletsBaclofen(Baclocur®) 10mg, 20mg, 30mg, 40mg. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- Patient aged 18 or more;
- Initiating a treatment with Baclocur®;
- Informed and having agreed to participate in the study;
- Covered by healthcare insurance.
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Baclofen TabletsAlso: Baclocur®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. | Drug | Adult patients starting a treatment with Baclocur® |
Primary outcome
Incidence of serious adverse events (SAE)
Time frame: 12-month follow-up period
To estimate the incidence of serious adverse events (SAE)
1 secondary outcome
Incidence of all adverse events over the 12-month follow-up
Time frame: 12-month follow-up period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2021.
Related trials for Alcohol Use Disorder
Recruiting
Tdcs And cogNitive traininG cOmbined for AUD (TANGO)
Alcohol Use Disorder, Addiction
Not yet recruitingPhase 1/2
Intravenous Acetate as an Adjunctive Treatment for Alcohol Withdrawal in Hospitalized Patients
Alcohol Withdrawal, Alcohol Abstinence
Not yet recruiting
PNF RCT to Decrease Alcohol Use and Increase HIV Prevention
HIV (Human Immunodeficiency Virus), Alcohol Misuse
RecruitingObservational study
SMART-r: Substance Monitoring and Active Relapse Tracking Repository
Alcoholism, Substance-Related Disorders
RecruitingPhase 2
Phase 2 Study of Apremilast in Women and Men With Alcohol Use Disorder
Alcohol Use Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Henri-Jean Aubin, MD, Ph.D principal investigator
Hospital Paul Brousse Villejuif France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alcohol Use Disorder, run by Ethypharm at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Olga Starchik, MD (+33626791157, starchik.olga@ethypharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of serious adverse events (SAE) (time frame: 12-month follow-up period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2021.