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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01931878
Other study ID # 1206010332
Secondary ID
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


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
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