Evaluation of the Efficacy and Safety of Metformin in the Myotonic Dystrophy Type 1 (Steinert's Disease)

PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

142

Participants

Timeline

Start Date

March 31, 2024

Primary Completion Date

October 31, 2026

Study Completion Date

October 31, 2026

Conditions
Steinert's DiseaseMyotonic Dystrophy 1Metformin
Interventions
DRUG

Treatment taken

Treatment (Metformin or placebo) will be administered orally and titrated following the same guideline that metformin in diabetic patient: start with a daily dose of 500 mg twice a day, given during or after meals; then increase to 1000 mg twice a day after a week. If digestive tolerance is good, treatment will be increased to a maximum of 1000 mg three times a day i.e. 3000 mg/day after another week.

Trial Locations (1)

92380

Neurology Department, Raymond-Poincaré hospital - APHP, Garches

All Listed Sponsors
lead

Assistance Publique - Hôpitaux de Paris

OTHER

NCT05532813 - Evaluation of the Efficacy and Safety of Metformin in the Myotonic Dystrophy Type 1 (Steinert's Disease) | Biotech Hunter | Biotech Hunter