The study will compare the efficacy and safety of brivaracetam with placebo in patients with Unverricht-Lundborg disease.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
50
* Active Substance: Brivaracetam * Pharmaceutical Form: Tablet * Concentration: 25 mg * Route of Administration: Oral use
* Active Substance: Brivaracetam * Pharmaceutical Form: Tablet * Concentration: 50 mg * Route of Administration: Oral use
* Active Substance: Placebo Pharmaceutical Form: Tablet * Concentration: 25 mg and 50 mg * Route of Administration: Oral use
Unnamed facility
Kuopio, Finland
Unnamed facility
Tampere, Finland
Unnamed facility
Marseille, France
Unnamed facility
Montpellier, France
Percent reduction from baseline on the Action Myoclonus score (Unified Myoclonus Rating Scale (UMRS) Section 4) at the end of the Treatment Period
Time frame: End of treatment period (Week 14 or early discontinuation visit)
Percent reduction from baseline on the functional disability score (UMRS Section 5) at the end of the Treatment Period
Time frame: End of treatment period (week 14 or early discontinuation visit)
Percent reduction from baseline on the stimulus sensitivity score (UMRS Section 3) at the end of the Treatment Period
Time frame: End of treatment period (week 14 or early discontinuation visit)
Percent reduction from baseline on the myoclonus patient questionnaire (UMRS Section 1) at the end of the Treatment Period
Time frame: End of treatment period (week 14 or early discontinuation visit)
Global Evaluation Scale by Investigator (I-GES) at the end of the Treatment Period
Time frame: End of treatment period (week 14 or early discontinuation visit)
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Unnamed facility
Bologna, Italy
Unnamed facility
Messina, Italy
Unnamed facility
Milan, Italy
Unnamed facility
Napoli, Italy
Unnamed facility
Heemstede, Netherlands
Unnamed facility
Heeze, Netherlands
...and 3 more locations