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

Restless Leg Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01931878
• Other study ID #: 1206010332
• Status: Active, not recruiting
• Phase: Phase 2
• First received: August 26, 2013
• Last updated: April 13, 2015
• Start date: September 2012
• Est. completion date: July 2016

Study information

• Verified date: April 2015
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

Please contact the PI for details about the clinical study.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psychomotor Agitation
• Restless Leg Syndrome
• Restless Legs Syndrome
• Syndrome

Intervention

Drug:
• incobotulinumtoxinA
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.
• 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.

Locations

Country	Name	City	State
United States	Yale Physcian Building	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	Merz Pharmaceuticals, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Restless Leg Syndrome Quality of Life questionnaire	The Restless Leg Syndrome Quality of Life questionnaire (QOL) is a set of 18 questions to understand the impact of RLS on your quality of life.	24weeks	No
Other	Visual Analog Scale	The Visual Analog Scale (VAS) consists of a line which represents the level of pain in 10 cms. The subject is required to make this line to show where your pain level is on this line (for example, at the 7cm mark).	24weeks	No
Other	Sleep Scale from the Medical Outcomes Study	The Sleep Scale questionaire from the Medical Outcomes Study (MOS) is a set of 12 questions to measure functioning and wellbeing due to sleep insufficiency.	24weeks	No
Primary	Restless Leg Syndrome Rating Scale	The Restless Legs Syndrome Rating Scale is a questionaire consisting of ten questions to subjectively rate the severity of related symptoms to this condition.	24weeks	No
Secondary	Epworth Sleep Scale	The Epworth Sleepiness Scale (EPS)is a set of 8 questions to evaluate daytime sleepiness.	24weeks	No