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

PHASE2CompletedINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

September 30, 2012

Primary Completion Date

August 31, 2015

Study Completion Date

August 31, 2015

Conditions
Restless Leg Syndrome
Interventions
DRUG

incobotulinumtoxinA

The subject may be randomly assigned to receive incobotulinum toxinA (Xeomin) , a neurotoxin Which is approved for use by the FDA for certain conditions. This study has a double blind cross over design. Cross over means that you will have two sets of injections. If the first set of injections is Xeomin, the second injections after a three month interval will be the inactive placebo. Double blind means neither the investigators nor the subject knows which one of the two (Xeomin or placebo) is received with the first or second injections.

DRUG

Placebo

The subject may be randomly assigned to receive Placebo which is an inactive test substance which has no active ingredient. In this protocol we use sterile salt water as placebo.This study has a double blind cross over design. Cross over means that you will have two sets of injections. If the first set of injections is placebo, the second injections after a three month interval will be active study drug. Double blind means neither the investigators nor the subject knows which one of the two (Xeomin or placebo) is received with the first or second injections.

Trial Locations (1)

06510

Yale Physcian Building, New Haven

All Listed Sponsors
collaborator

Merz North America, Inc.

INDUSTRY

lead

Yale University

OTHER

NCT01931878 - Investigation of Efficacy of incobotulinumtoxinA (Xeomin) in Relieving Symptoms of Restless Leg Syndrome. | Biotech Hunter | Biotech Hunter