[Gabapentin for spasticity: a randomized, double-blind, placebo-controlled trial].

BACKGROUND AND OBJECTIVE

We aimed to demonstrate the efficacy and safety of gabapentin for the treatment of spasticity in patients with upper motor neuron syndrome.

PATIENTS AND METHOD

Thirty patients with pyramidal-tract lesions were randomized to up to 3,600 mg/day of gabapentin (n = 15) or placebo (n = 15) in a double-blind, pilot 10-week trial. The primary efficacy variable was the Ashworth Scale score. Secondary variables included the Spasm Frequency Scale, maximal range of movement, H/M Amplitude Ratio, and the Barthel Index for quality of life. Adverse events were recorded. All data were analyzed on an intent-to-treat basis.

RESULTS

Demographic and baseline characteristics were similar between the 2 treatment groups. The gabapentin group showed significant improvement in Ashworth Scale total scores, and scores for individual affected muscle groups. Fifteen of the randomized patients had spasms; the total Spasm Frequency Scale score was not significantly different between groups. Nevertheless, when affected individual muscle groups were analyzed, a significant effect of gabapentin vs placebo was observed at all visits. Gabapentin did not modify the scores of the range of movement, the H/M Amplitude Ratio, or the Barthel Index tests. No gait or displacement impairment were seen during treatment with gabapentin. Related adverse events occurred less frequently in the gabapentin group, and fewer gabapentin patients withdrew because of adverse events.

CONCLUSIONS

Gabapentin demonstrated efficacy and safety at doses between 2,700 and 3,600 mg/day as a therapy for the spasticity associated with the upper motor neuron syndrome.