The study will compare the efficacy and safety of Brivaracetam with placebo in patients with Unverricht- Lundborg Disease (ULD).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
56
* Pharmaceutical Form: Tablet * Concentration: 2.5 mg, 25 mg and 50 mg * Route of Administration: Oral use
* Pharmaceutical Form: Tablet * Concentration: 2.5 mg * Route of Administration: Oral use
* Pharmaceutical Form: Tablet * Concentration: 25 mg * Route of Administration: Oral use
135
San Francisco, California, United States
133
Gainesville, Florida, United States
132
New York, New York, United States
Percent Change From Baseline to the End of Treatment Period on the Action Myoclonus Score (Unified Myoclonus Rating Scale (UMRS) Section 4)
The range for Action Myoclonus Score (centrally read) is 0 (best) - 160 (worst). Percent change from Baseline = 100 X ((Baseline UMRS4 - Treatment UMRS4) / Baseline UMRS4). Baseline is defined as the last non-missing value prior to or on Randomization Visit.
Time frame: From Baseline to End of Treatment Period (Week 14 or Early Discontinuation Visit)
Percent Change From Baseline to the End of Treatment Period on the Functional Disability Score (Unified Myoclonus Rating Scale (UMRS) Section 5)
The range for Functional Disability Score is 0 (best) to 28 (worst). Percent change from Baseline = 100 X ((Baseline UMRS5 - Treatment UMRS5) / Baseline UMRS5). Baseline is defined as the last non-missing value prior to or on Randomization Visit.
Time frame: Baseline to End of Treatment Period (Week 14 or Early Discontinuation Visit)
Percent Change From Baseline to the End of Treatment Period on the Stimulus Sensitivity Score (Unified Myoclonus Rating Scale (UMRS) Section 3)
The range for Stimulus Sensitivity Score is 0 (best) to 17 (worst). Percent change from Baseline = 100 X ((Baseline UMRS3 - Treatment UMRS3) / Baseline UMRS3). Baseline is defined as the last non-missing value prior to or on Randomization Visit.
Time frame: Baseline to End of Treatment Period (Week 14 or Early Discontinuation Visit)
Percent Change From Baseline to the End of Treatment Period on the Myoclonus Patient Questionnaire (Unified Myoclonus Rating Scale (UMRS) Section 1)
The range for Myoclonus Patient Questionnaire is 0 (best) to 44 (worst). Percent change from Baseline = 100 X ((Baseline UMRS1 - Treatment UMRS1) / Baseline UMRS1). Baseline is defined as the last non-missing value prior to or on Randomization Visit.
Time frame: Baseline to End of Treatment Period (Week 14 or Early Discontinuation Visit)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
* Pharmaceutical Form: Tablet * Concentration: 50 mg * Route of Administration: Oral use
131
Charlottesville, Virginia, United States
151
Vancouver, British Columbia, Canada
150
Montreal, Quebec, Canada
152
Québec, Quebec, Canada
100
Helsinki, Finland
122
Bron, France
121
Lille, France
...and 8 more locations
Global Evaluation Score (Investigator) at the End of Treatment Period
The Global Evaluation Scale Score (Investigator) ranges from 1 (Marked worsening) to 7 (Marked improvement).
Time frame: End of Treatment Period (Week 14 or Early Discontinuation Visit)