Open-label pilot trial of levetiracetam for cramps and spasticity in patients with motor neuron disease.

Cramps and spasticity impair quality of life and function in patients with motor neuron diseases, and there are no proven treatments for these problems. We conducted a pilot trial to determine if treatment with levetiracetam was associated with a reduction in cramp severity, cramp frequency, tonic or phasic spasticity. We used an open-label repeated measures pilot trial of 20 patients, comparing cramp and spasticity scores over a 3-month baseline versus nine months on treatment. Cramp and spasticity scores were stable over a 3-month baseline. Shortly after starting levetiracetam, there was a significant reduction in cramp severity and frequency, which persisted for the duration of this year-long study. There was also a reduction in phasic but not tonic spasticity. Levetiracetam was well tolerated. Our results justify a placebo-controlled study of levetiracetam for treatment of cramps and spasticity in patients with motor neuron diseases, and suggest that this can be accomplished with a small number of subjects followed for a short time.