OBJECTIVES: This study had two main objectives: 1. To enable @entity1 with @entity746 ( @entity746 ) who had not participated in previous @entity10891 trials to receive @entity10891 therapy, and 2. To expand safety experience with the drug in a broad @entity1 population. METHODS: This was a Phase IIIb multicentre, multinational, open-label, uncontrolled single treatment study of @entity10891 . @entity1 with diagnosed possible or probable @entity746 were administered 100 mg of @entity10891 /day (50 mg b.i.d.). Clinical and laboratory adverse events were recorded every month for the first 3 months and thereafter at 3-monthly intervals. RESULTS: 8383 @entity1 from 44 countries were entered into the study; 7916 of these @entity1 with recorded data were administered the study drug. The mean duration of @entity10891 treatment was 202.1 days, with a range of 1-630 days. The most frequently reported serious and non-serious adverse events were common symptoms of @entity746 ( @entity1576 and @entity1282 ), and only 1.9% of serious adverse events were considered to be related to the study drug. CONCLUSIONS: The safety results with this broad population (over 10% of the estimated @entity746 population worldwide) were consistent with those previously reported from placebo-controlled trials. No increase in adverse events and no unexpected adverse events were observed.

The Rilutek ( XXXX ) Global Early Access Programme: an open-label safety evaluation in the treatment of @entity746 .

@entity1 :: ('9606', 'Species') :: ['Patients', 'patients', 'patient'] @entity10891 :: ('MESH:D019782', 'Chemical') :: ['riluzole'] @entity1576 :: ('MESH:D012131', 'Disease') :: ['respiratory symptoms'] @entity1282 :: ('MESH:D003680', 'Disease') :: ['dysphagia'] @entity746 :: ('MESH:D000690', 'Disease') :: ['ALS', 'amyotrophic lateral sclerosis']
@entity10891 :: (MESH:D019782,Chemical) :: ['riluzole']
