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

• Status: Completed
• Trial end date: 2015-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yale University
• Collaborators: Merz North America, Inc.; Merz Pharmaceuticals, LLC
• Treatments: abobotulinumtoxinA; Botulinum Toxins, Type A; incobotulinumtoxinA; onabotulinumtoxinA

Criteria

Inclusion Criteria:

• Subjects 18- 80 years of age, both sexes, all races and ethnic groups.

• Diagnosis of restless legs syndrome

• Disease duration longer than 3 months

• Restless Leg Syndrom Rating Scale score of 11 or above (moderate and above)

• Subjects who are eligible to be treated with a botulinum toxin for a therapeutic reason based upon the physicians' clinical experience.

• Subjects who are able to read, speak, and understand English.

Exclusion Criteria:

• Existing significant acute medical condition (i.e. cardiovascular, endocrine, hematologic, neoplastic, infectious, or autoimmune disorders).

• Pregnancy or planned pregnancy (determined by urine pregnancy test). Women of childbearing age should use a reliable mode of contraception during the study period (abstinence, etc).

• Active breast feeding.

• Enrollment in any clinical trial (currently or within the past 3 months) in which treatments are imposed by a protocol.

• Any subject for whom botulinum toxin treatment would be contraindicated; known allergy or sensitivity to medication.

• Subjects who are younger than 18 years of age.

• Neuromuscular-junction disorders.

• Evidence of acute pathology by neuro-imaging.

• Axis I diagnosis determined by a neurologist or psychiatrist.

• Anesthetic medications within two weeks and corticosteroid injections within 4 weeks of enrollment.

• Subject has received botulinum toxin injections in the past 4 months.