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

NCT01931878 | Completed Phase 2 Results

• 1 other identifier: 1206010332
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Restless Leg Syndrome

Keywords

Restless Legs Syndrome; Leg pain; Sleep; Dysesthesias; incobotulinumtoxin

Outcome Measures

Primary Outcomes (1)

• Mean Total Restless Leg Syndrome Rating Scale Score

  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)

  6 weeks

Secondary Outcomes (1)

• Number of Patients Whose Patient Global Impression of Change (PGIC) Moderately or Much Improved

  6 weeks

Other Outcomes (1)

• Patients With Pain on Visual Analog Scale <4

  6 weeks

Study Arms (2)

Placebo , saline

PLACEBO COMPARATOR

The subject may be randomly assigned to receive Placebo, saline

Drug: Placebo

IncobotulinumtoxinA Treatment

ACTIVE COMPARATOR

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

Drug: incobotulinumtoxinA

Interventions

incobotulinumtoxinA DRUG

The 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.

Also known as: Xeomin

IncobotulinumtoxinA Treatment

Placebo DRUG

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.

Also known as: Sterile saline water

Placebo , saline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yale University: lead
• Merz North America, Inc.: collaborator

Study Sites (1)

Yale Physcian Building

New Haven, Connecticut, 06510, United States

Location

Related Publications (1)

• 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.

  PMID: 30274305 DERIVED

MeSH Terms

Conditions

Restless Legs Syndrome; Paresthesia

Interventions

incobotulinumtoxinA

Condition Hierarchy (Ancestors)

Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Parasomnias; Mental Disorders; Somatosensory Disorders; Sensation Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Relatively small number of participants. crossover not parallel design

Results Point of Contact

• Title: Bahman Jabbari M.D.
• Organization: Yale University School of Medicine

bahman.jabbari@yale.edu

203-737-2464

Study Officials

• Bahman Jabbari, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2013
• First Posted: August 29, 2013
• Study Start: September 1, 2012
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: March 21, 2016
• Results First Posted: March 21, 2016

Record last verified: 2016-02

Locations

US (1)