The purpose of this study is to determine if oral treatment with ONO-2506PO in patients diagnosed with ALS, who have had onset of muscle weakness within 14 months of randomization, could lead to the slowing of decline in respiratory function, functional status, muscle strength, quality of life and survival compared with placebo group.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
420
1200 mg QD / 18 months
0 mg QD / 18 months
Rate of decline of respiratory function determined as SVC over the 12 month treatment period
Time frame: 12 months
Survival
Time frame: 12, 18 months
Functional Assessment (ALSFRS-R)
Time frame: 12, 18 months
Muscle Strength (MRC muscle score)
Time frame: 12, 18 months
Quality of Life
Time frame: 12, 18 months
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L. Boltzmann Forschungsinstitut, Neurologische Abteilung, Kaiser Franz Josef Hospital, Wien
Vienna, Austria
UCL Saint-Luc
Brussels, Belgium
UZ Leuven
Leuven, Belgium
Hopital Roger Salengro - Clinique Neurologique, Neurologie A
Lille, France
Hopital Duruytren
Limoges, France
Hopital de la Timone
Marseille, France
Hopital de Chauliac
Montpellier, France
Hopital l-Archet 1
Nice, France
Hopital LaPitie Salpetriere
Paris, France
Charite Campus Virchow, ALS Ambulanz
Berlin, Germany
...and 16 more locations