[Tolerance of riluzole in a phase IIIb clinical trial].
Within the framework of an early drug access programme launched in 1995, a multicentre open study was initiated in France in order to assess, inter alia, the safety of riluzole (50 mg twice a day) in a total of 2069 patients from 28 centres. This programme, a phase IIIb study with direct individual benefit, had two main objectives: to enable patients to receive riluzole therapy pending regulatory approval and commercial availability and to provide further data on the safety of riluzole in a broader ALS population. The most frequent adverse events related to riluzole treatment were: asthenia, nausea and elevation of serum transaminase levels. These observations, similar to data derived from previous pivotal clinical trials, confirm that riluzole has a satisfactory tolerability profile.
Lacomblez
L
L
AP-HP, Fédération de Neurologie Mazarin, Hôpital de la Pitié-Salpêtrière, Paris.
Dib
M
M
Doppler
V
V
Faudet
A
A
Robin
V
V
Salachas
F
F
Bensimon
G
G
Meininger
V
V
D000368:Aged; D000690:Amyotrophic Lateral Sclerosis / Q000150:complications* / Q000188:drug therapy; D005260:Female; D005602:France / Q000453:epidemiology; D006801:Humans; D008297:Male; D008875:Middle Aged; D018696:Neuroprotective Agents / Q000009:adverse effects* / Q000627:therapeutic use; D011358:Product Surveillance, Postmarketing; D019782:Riluzole / Q000009:adverse effects* / Q000627:therapeutic use
D018696:Neuroprotective Agents; D019782:Riluzole