Overview

This trial is active, not recruiting.

Condition restless leg syndrome
Treatments incobotulinumtoxina, placebo
Phase phase 2
Sponsor Yale University
Collaborator Merz Pharmaceuticals, LLC
Start date September 2012
End date July 2016
Trial size 20 participants
Trial identifier NCT01931878, 1206010332

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model crossover assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Placebo Comparator)
The subject may be randomly assigned to receive Placebo, saline
placebo Sterile saline water
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.
(Active Comparator)
The subjects will be randomized to received injections of active study drug, incobotulinumtoxinA (Xeomin)
incobotulinumtoxina Xeomin
The subject may be randomly assigned to receive Xeomin which is an active drug for the first treatment intervention. Xeomin is 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.

Primary Outcomes

Measure
Restless Leg Syndrome Rating Scale
time frame: 24weeks

Secondary Outcomes

Measure
Epworth Sleep Scale
time frame: 24weeks

Eligibility Criteria

Male or female participants at least 18 years old.

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 - IRLS 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.

Additional Information

Official title Investigation of Efficacy of incobotulinumtoxinA (Xeomin) in Relieving Symptoms of Restless Leg Syndrome.
Principal investigator Bahman Jabbari, MD
Description Please contact the PI for details about the clinical study.
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by Yale University.