About this trial
The study team hypothesize that non-diabetic patients with Myotonic dystrophy type I (DM1) will improve their symptoms, especially their motor deficit which is the main feature of the disease, because of the splicing defect correction by metformin.
The primary objective of the study is to evaluate the efficacy of metformin vs placebo, on the improvement of muscle function in patients with DM1 compared to its placebo.
As the secondary objectives, the study aims:
* To evaluate the safety of metformin on patient with DM1. * To evaluate the efficacy of metformin vs placebo on:
1. The hand-grip strength; 2. The thumb-index pinch strength; 3. The locomotor function; 4. The respiratory function; 5. The cardiac function; 6. The quality of life; 7. The daily and social activity.
Eligibility criteria
Qualifiers
DM1 disease confirmed by genetic analysis
Men and women between 18 and 70 years of age.
Preserved walking abilities (stick assistance possible)
MIRS score 3 or 4
Disqualifiers
Pregnant or breast-feeding women
Men with an intention to conceive a child during the time of the study
Contraindications to Metformin (hypersensitivity to metformin or to one of the excipients)
Patient requiring tracheotomy or
Trial design
Treatments tested in this trial
- Treatment taken