To investigate the safety and the efficacy of perampanel in patients with sporadic amyotrophic lateral sclerosis
To evaluate the effect of peramanel for 48 weeks on progression of disease in subjects with ALS, as measured by ALS Functional Rating Scale-Revised (ALSFRS-R)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
66
4mg/d or 8mg/d
placebo
Kitasato University East Hospital
Kanagawa, Japan
Kumamoto Saishunso National Hospital
Kumamoto, Japan
Nagoya University Hospital
Nagoya, Japan
Change in ALS Functional rating scale
Time frame: 48 weeks
Change in ALS Functional rating scale
Time frame: 12, 24, 36, and 48 weeks
Manual Muscle Test
Time frame: 12, 24, 36, and 48 weeks
Percent-predicted forced vital capacity
Time frame: 12, 24, 36, and 48 weeks
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Okayama University Hospital
Okayama, Japan
Hokkaido University Hospital
Sapporo, Japan
Tohoku University Hospital
Sendai, Japan
Shiga University of Medical Science Hospital
Shiga, Japan
Tokyo Medical University
Tokyo, Japan
The University of Tokyo Hospital
Tokyo, Japan
Tokyo Metropolitan Neurological Hospital
Tokyo, Japan
...and 2 more locations