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

Phase 2

Completed

• Conditions: Restless Leg Syndrome
• Interventions: Drug: Placebo; Drug: incobotulinumtoxinA

• Registration Number: NCT01931878
• Lead Sponsor: Yale University

Brief 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.

Detailed Description

Please contact the PI for details about the clinical study.

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2013-08-26
• Study First Submitted QC: 2013-08-26
• Study First Posted: 2013-08-29
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Results First Submitted: 2015-09-04
• Status Verified: 2016-02
• Results First Submitted QC: 2016-02-23
• Last Update Submitted: 2016-02-23
• Results First Posted: 2016-03-21
• Last Update Posted: 2016-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo , saline	Placebo	The subject may be randomly assigned to receive Placebo, saline
IncobotulinumtoxinA Treatment	incobotulinumtoxinA	The subjects will be randomized to received injections of active study drug, incobotulinumtoxinA (Xeomin)

Primary Outcome Measures

Name	Time	Method
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)

Secondary Outcome Measures

Name	Time	Method
Number of Patients Whose Patient Global Impression of Change (PGIC) Moderately or Much Improved	6 weeks	The PGIC is a 7 point scale that requires the clinician to assess how much the patient's pain has improved or worsened relative to a baseline state at the beginning of the intervention. and rated as: No change (or condition has gotten worse) (1) Almost the same, hardly any change at all (2) A little better, but no noticeable change (3) Somewhat better, but the change has not made any real difference (4) Moderately better, and a slight but noticeable change (5) Better and a definite improvement that has made a real and worthwhile difference (6) A great deal better and a considerable improvement that has made all the difference (7)improved; This outcome is number of patients who chose a 5 or above on the PGIC 6 weeks after treatment.

Trial Locations

Locations (1)

Yale Physcian Building; 🇺🇸 New Haven, Connecticut, United States