Lack of efficacy of riluzole in the treatment of peripheral neuropathic pain conditions

Objective: To assess the efficacy, tolerability, and safety of riluzole in the treatment of peripheral neuropathic pain conditions. Background: Both b asic and clinical research has demonstrated that drugs with sodium channel and NMDA antagonism can be effective in alleviating neuropathic pain. Riluz ole, a drug currently used for treatment of ALS, possesses these properties . It was hypothesized that riluzole would be effective in reducing the pain in subjects with peripheral neuropathic pain. Methods: Two randomized, pla cebo-controlled, crossover studies were performed at two sites. Study 1 com pared 100 mg/day of riluzole (the currently recommended dosage for treatmen t of ALS) versus placebo, and Study 2 compared 200 mg/day of riluzole versu s placebo, Each treatment phase (both studies) was 2 weeks long, separated by 2-week wash-out periods. Outcome measures included change in the score o n a 100-mm pain intensity visual analog scale, the Neuropathic Pain Scale, allodynia, hyperalgesia, and preference for study treatment phase. Results: Twenty-two subjects completed Study 1, and 21 subjects completed Study 2. Four subjects (two from each study) discontinued the study because of intol erable side effects. No statistical difference was found for any study outc ome measure between riluzole and placebo for either study. In Study 1, pain intensity was more likely to increase than decrease with riluzole (mean tr eatment difference 8.7 mm; 95% CI -19.5 to +2.1 mm). In Study 2, very sligh t pain reduction was observed with riluzole compared with placebo (mean tre atment difference 1.4 mm; 95% CI -5.1 to +8.0 mm). In both studies, the maj ority of subjects chose "no change" in pain on the category relief scale af ter placebo and riluzole treatment phases. On study completion, no treatmen t preference was reported by 76% of the subjects in Study 1 and by 61% of t he subjects in Study 2. Conclusions: Doses of riluzole at (100 mg) or above (200 mg) those used for the treatment of ALS were not effective in allevia ting peripheral neuropathic pain.