L-citrulline and Metformin in Becker's Muscular Dystrophy
NCT ID: NCT02018731
Last Updated: 2016-05-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
20 participants
INTERVENTIONAL
2013-06-30
2015-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
L-citrulline and Metformin in Duchenne's Muscular Dystrophy
NCT01995032
Improved Muscle Function in Duchenne Muscular Dystrophy Through L-Arginine and Metformin
NCT02516085
Evaluation of the Efficacy and Safety of Metformin in the Myotonic Dystrophy Type 1 (Steinert's Disease)
NCT05532813
Clinical Study to Evaluate the Efficacy and Safety of Givinostat in Ambulant Patients With Becker Muscular Dystrophy
NCT03238235
Defining Endpoints in Becker Muscular Dystrophy
NCT05257473
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Half of the patients will be treated with metformin during the first 6 weeks of the study. The other patients will receive initially L-citrulline for 6 weeks, before all patients will be treated with the combination therapy (metformin and L-citrulline) for another 6 week period.
The study lasts 12 weeks and includes the screening visit and 3 further visits at baseline, week 6 and week 12.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Metformin and Metformin & L-Citrulline
1500 mg/d metformin for 6 weeks, followed by 1500 mg/d metformin and 15 g/d L-citrulline for 6 further weeks
Metformin and Metformin & L-Citrulline
L-Citrulline and Metformin & L-Citrulline
15 g/d L-citrulline for 6 weeks, followed by 1500 mg/d metformin and 15 g/d L-citrulline for 6 further weeks
L-Citrulline and Metformin & L-Citrulline
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Metformin and Metformin & L-Citrulline
L-Citrulline and Metformin & L-Citrulline
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Molecular or immunohistochemical diagnosis of BMD
* ambulant at the time point of screening
Exclusion Criteria
* Use of L-Arginine, L-Citrulline or Metformin within the last 3 months
* Other chronic disease or relevant limitation of renal, liver, heart function according to discretion of investigator
* known hypersensitivity to L-citrulline or metformin
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University Hospital, Basel, Switzerland
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Dirk Fischer, MD
Role: PRINCIPAL_INVESTIGATOR
University Children's Hospital Basel
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University Children's Hospital
Basel, Canton of Basel-City, Switzerland
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
BMD01
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.