Clinical trial NCT01931878: Investigation of Efficacy of incobotulinumtoxinA (Xeomin) in Relieving Symptoms of Restless Leg Syndrome.
Official title: Investigation of Efficacy of incobotulinumtoxinA (Xeomin) in Relieving Symptoms of Restless Leg Syndrome.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Restless Leg Syndrome
Keywords: Restless Legs Syndrome
Leg pain
Sleep
Dysesthesias
incobotulinumtoxin
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: Merz North America, Inc.
First posted: 2013-08-29
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Mean Total Restless Leg Syndrome Rating Scale Score
timeFrame: 6 weeks
Secondary outcomes:
measure: Number of Patients Whose Patient Global Impression of Change (PGIC) Moderately or Much Improved
timeFrame: 6 weeks
Other outcomes:
measure: Patients With Pain on Visual Analog Scale <4
timeFrame: 6 weeks
Locations:
city: New Haven
country: United States
facility: Yale Physcian Building
state: Connecticut
Study officials:
affiliation: Yale University
name: Bahman Jabbari, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mittal SO, Machado D, Richardson D, Dubey D, Jabbari B. Botulinum Toxin in Restless Legs Syndrome-A Randomized Double-Blind Placebo-Controlled Crossover Study. Toxins (Basel). 2018 Sep 29;10(10):401. doi: 10.3390/toxins10100401.