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

NCT ID: NCT01931878

Last Updated: 2016-03-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2015-08-31

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.

Conditions

Restless Leg Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Placebo , saline

The subject may be randomly assigned to receive Placebo, saline

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: 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.

IncobotulinumtoxinA Treatment

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

Group Type: ACTIVE_COMPARATOR

incobotulinumtoxinA

Intervention Type: 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.

Interventions

incobotulinumtoxinA

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

Other Intervention Names

Xeomin; Sterile saline water

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merz North America, Inc.

INDUSTRY

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bahman Jabbari, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Yale Physcian Building

New Haven, Connecticut, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 30274305 (View on PubMed)

Other Identifiers

1206010332

Identifier Type: -

Identifier Source: org_study_id