Conditions: Unverricht-Lundborg Disease
Keywords: Unverricht-Lundborg Disease Baltic Myoclonus Progressive Myoclonic Epilepsies Myoclonus Brivaracetam
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 56
Healthy volunteers: no

Brief summary:
The study will compare the efficacy and safety of Brivaracetam with placebo in patients with Unverricht- Lundborg Disease (ULD).

Detailed description:

Arms:
arm 1: Placebo Placebo twice a day (bid), 14 weeks (2 week Up-Titration Period + 12 week Maintenance Period) arm 2: Brivaracetam (BRV) 5 mg/day 5 mg twice a day (bid) using 2.5 mg tablets for 12 weeks (after 2 week Up- Titration Period) arm 3: Brivaracetam (BRV) 150 mg/day 150 mg twice a day (bid) using 25 mg and 50 mg tablets for 12 weeks (after 2 week Up-Titration Period)

Interventions: intervention 1: Placebo intervention 2: BRV 2.5 mg intervention 3: BRV 25 mg intervention 4: BRV 50 mg
Intervention descriptions: intervention 1: * Pharmaceutical Form: Tablet
* Concentration: 2.5 mg, 25 mg and 50 mg
* Route of Administration: Oral use intervention 2: * Pharmaceutical Form: Tablet
* Concentration: 2.5 mg
* Route of Administration: Oral use intervention 3: * Pharmaceutical Form: Tablet
* Concentration: 25 mg
* Route of Administration: Oral use intervention 4: * Pharmaceutical Form: Tablet
* Concentration: 50 mg
* Route of Administration: Oral use

Protocol document: