AN OPEN STUDY OF RILUZOLE VERSUS RILUZOLE PLUS GABAPENTIN IN AMYOTROPHIC LATERAL SCLEROSIS

A randomised open study has been carried out to evaluate the efficacy of riluzole versus riluzole plus gabapentin in 50 patients (23 males, 27 females) affected by amyotrophic lateral sclerosis (ALS), who received the diagnosis according to El Escorial WFN criteria. At baseline, the mean age of the patients was 58.8 ± 11.7 years and the mean disease duration was 11.4 ± 5.9 months. Twenty patients had bulbar and 30 spinal onset. Twenty-eight patients were randomly assigned to riluzole (100 mg/day) and 22 to riluzole plus gabapentin at the initial dose of 300 mg/day, slowly increased to 1800 mg/day. Informed consent was obtained in all cases. Before treatment, each patient underwent neurological examination, Appel rate scale, pulmonary function tests, electromyography, and transcranial magnetic stimulation. Clinical examination and electrophysiologic tests were repeated at three-month intervals. Over the course of the trial, 4 patients (8%) were lost to follow-up and 16 (32%, 9 in the riluzole and 7 in the riluzole plus gabapentin group) died. The mean age at death was 65.0 ± 6.5 years after a mean disease duration of 20.8 ± 7.9 months (range 13–36). There was no significant difference in response to treatment when severity and duration of the disease were compared in the two groups.