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. Author manuscript; available in PMC: 2013 Mar 6.
Published in final edited form as: Lancet Neurol. 2008 Aug;7(8):742–755. doi: 10.1016/S1474-4422(08)70165-0

Table 2.

Summary of published randomized, double blind, placebo-controlled trials of riluzole in patients with ALS.

Study Participants Treatment Duration Primary Outcomes Main Results
Bensimon et al, 1994 N=155
Age 20–75 yrs and FVC >60% predicted and onset of symptoms ≤ 5 yrs		 RLZ 100 mg/d or PLC 573 days (median follow up) Tracheostomy-free survival; Change in functional status

  • 74% of RLZ patients vs 58% of PLC patients had tracheostomy-free survival at 12 months (P=0.014)

  • Median survival was 532 days with RLZ vs 449 days with PLC

  • No significant difference in rate of deterioration of limb (P=0.22) or bulbar (P=0.42) function between RLZ and PLC
Lacomblez et al, 1996 N=959
Age 18–75 yrs and FVC ≥ 60% predicted and onset of symptoms ≤ 5 yrs		 RLZ 50 mg/d or 100 mg/d or 200 mg/d or PLC 548 days (median follow up) Tracheostomy-free survival

  • After adjustment for prognostic factors, RLZ 50 mg/d, 100 mg/d, and 200 mg/d decreased the risk of tracheostomy or death at 18 months by 24%, 35%, and 39%, respectively (P<0.05)
Bensimon et al, 2002 N=168
Age >75 yrs and/or FVC <60% predicted and/or onset of symptoms >5 yrs		 RLZ 100 mg/d or PLC 548 days (median follow up) Tracheostomy-free survival

  • No significant difference in tracheostomy-free survival between RLZ and PLC (P=0.93)

FVC=forced vital capacity. PLC=placebo. RLZ=riluzole.