This study will test whether botulinum toxin (Botox) may relieve the uncomfortable sensations
patients with restless legs syndrome (RLS) experience. RLS is a common movement disorder that
causes sensory discomfort and restlessness, most often in the legs, which improves with
movement. Although medications are available to treat the disorder, many people experience
side effects that prevent them from continuing on the medication. The Food and Drug
Administration has approved Botox for other movement disorders and for some cosmetic uses.
People 18 years of age or older with moderate to severe RLS who have been taking RLS
medications for more than 6 weeks before entering the study may be eligible to participate.
Candidates are screened with a medical history, physical and neurological examinations, blood
tests and, for women who can become pregnant, a urine pregnancy test.
Participants are randomly assigned to receive injections of either Botox or placebo (salt
water) into up to nine areas of the legs. The correct location of the muscles to be injected
is determined by electromyography (EMG), a test that measures the electrical activity of
muscles. For surface EMG, electrodes (small metal disks) are filled with a conductive gel and
taped to the skin. Needle EMG involves inserting a needle into a muscle. Both methods are
used in this study.
At 2 and 4 weeks after the injections, subjects are interviewed by telephone and asked to
describe their symptoms, side effects and any improvement they may have noticed. After 12
weeks they return to NIH for injections with the alternate compound; that is, those who
received Botox previously are given placebo for the second set of injections, and vice-versa.
Subjects are again contacted by telephone 2 and 4 weeks after the injections to report their
symptoms, side effects and benefits.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
National Institute of Neurological Disorders and Stroke (NINDS)
Treatments:
abobotulinumtoxinA Botulinum Toxins Botulinum Toxins, Type A incobotulinumtoxinA onabotulinumtoxinA