Who is sponsoring NCT01931878?

NCT01931878 is sponsored by Yale University.

What condition does NCT01931878 study?

NCT01931878 studies Restless Leg Syndrome.

What drugs are being tested in NCT01931878?

Interventions: incobotulinumtoxinA, Placebo.

What is the status of NCT01931878?

NCT01931878 is currently COMPLETED.

Last reviewed 2016-02-23 · How we verify

Investigation of Efficacy of incobotulinumtoxinA (Xeomin) in Relieving Symptoms of Restless Leg Syndrome.

NCT01931878 Phase 2 COMPLETED Results posted

The purpose of this research study is to compare the safety and effectiveness of local injections of botulinum toxin A (Xeomin®) to an inactive test substance (placebo) in a medical condition called Restless Leg Syndrome. This study has a double blind cross over design. Cross over means that you will have two sets of injections. The first set of injections can be either Xeomin or placebo. The order of injection will be reversed at the three month point following the first injection. Double blind means neither the investigators nor you know which one of the two (Xeomin or placebo) you received.

Details

Lead sponsor	Yale University
Phase	Phase 2
Status	COMPLETED
Enrolment	24
Start date	2012-09
Completion	2015-08

Conditions

Restless Leg Syndrome

Interventions

incobotulinumtoxinA
Placebo

Primary outcomes

Mean Total Restless Leg Syndrome Rating Scale Score — 6 weeks
The Restless Legs Syndrome Rating Scale uses 10 questions, each scored 0-4, with higher scores representing more severe symptoms. Score ranges from 1-40. Scoring criteria are: Mild (score 1-10); Moderate (score 11-20); Severe (score 21-30); Very severe (score 31-40)

Countries

United States