93
Participants
Start Date
December 1, 2024
Primary Completion Date
September 1, 2027
Study Completion Date
September 1, 2027
Baclofen 30 mg
"* baclofen 10 mg capsule (for the 30 mg-baclofen 30 mg arm)~* Dosage: 3 capsules of baclofen 10 mg per day~* route of administration: Oral~* duration of treatment: Total duration of treatment is 13 weeks including 1 week of dose escalation, 11 weeks of maintenance at full dose, and 1 week of dose de-escalation"
Baclofen 60 mg
"* baclofen 20 mg capsule (for the 60 mg baclofen arm)~* Dosage: 3 capsules of baclofen 20 mg per day~* route of administration: Oral~* duration of treatment: Total duration of treatment is 13 weeks including 1 week of dose escalation, 11 weeks of maintenance at full dose, and 1 week of dose de-escalation"
Placebo
"* placebo capsule (for the placebo arm)~* Dosage:3 capsules of placebo per day~* route of administration: Oral~* duration of treatment: Total duration of treatment is 13 weeks including 1 week of dose escalation, 11 weeks of maintenance at full dose, and 1 week of dose de-escalation"
Hôpital Edouard Herriot, Lyon
Centre Hospitalier le Vinatier, Bron
Hospices Civils de Lyon
OTHER