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

Restless Leg Syndrome research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Restless Leg Syndrome

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:incobotulinumtoxinAThe 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:PlaceboThe 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.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Placebo , salineThe subject may be randomly assigned to receive Placebo, saline

IncobotulinumtoxinA TreatmentThe subjects will be randomized to received injections of active study drug, incobotulinumtoxinA (Xeomin)

Study Status

Completed

Start Date: September 2012

Completed Date: August 2015

Phase: Phase 2

Type: Interventional

Design:

Primary Outcome: Mean Total Restless Leg Syndrome Rating Scale Score

Secondary Outcome: Number of Patients Whose Patient Global Impression of Change (PGIC) Moderately or Much Improved

Study sponsors, principal investigator, and references

Principal Investigator: Bahman Jabbari, MD

Lead Sponsor: Yale University

Collaborator: Merz North America, Inc.

More information:https://clinicaltrials.gov/show/NCT01931878

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