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

Primary Purpose

Restless Leg Syndrome

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
incobotulinumtoxinA
Placebo
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Restless Leg Syndrome focused on measuring Restless Legs Syndrome, Leg pain, Sleep, Dysesthesias, incobotulinumtoxin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Yale Physcian Building

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo , saline

IncobotulinumtoxinA Treatment

Arm Description

The subject may be randomly assigned to receive Placebo, saline

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Number of Patients Whose Patient Global Impression of Change (PGIC) Moderately or Much Improved
The PGIC is a 7 point scale that requires the clinician to assess how much the patient's pain has improved or worsened relative to a baseline state at the beginning of the intervention. and rated as: No change (or condition has gotten worse) (1) Almost the same, hardly any change at all (2) A little better, but no noticeable change (3) Somewhat better, but the change has not made any real difference (4) Moderately better, and a slight but noticeable change (5) Better and a definite improvement that has made a real and worthwhile difference (6) A great deal better and a considerable improvement that has made all the difference (7)improved This outcome is number of patients who chose a 5 or above on the PGIC 6 weeks after treatment.

Full Information

First Posted
August 26, 2013
Last Updated
February 23, 2016
Sponsor
Yale University
Collaborators
Merz North America, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01931878
Brief Title
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

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
Merz North America, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Restless Leg Syndrome
Keywords
Restless Legs Syndrome, Leg pain, Sleep, Dysesthesias, incobotulinumtoxin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo , saline
Arm Type
Placebo Comparator
Arm Description
The subject may be randomly assigned to receive Placebo, saline
Arm Title
IncobotulinumtoxinA Treatment
Arm Type
Active Comparator
Arm Description
The subjects will be randomized to received injections of active study drug, incobotulinumtoxinA (Xeomin)
Intervention Type
Drug
Intervention Name(s)
incobotulinumtoxinA
Other Intervention Name(s)
Xeomin
Intervention Description
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
Intervention Name(s)
Placebo
Other Intervention Name(s)
Sterile saline water
Intervention Description
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.
Primary Outcome Measure Information:
Title
Mean Total Restless Leg Syndrome Rating Scale Score
Description
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)
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Number of Patients Whose Patient Global Impression of Change (PGIC) Moderately or Much Improved
Description
The PGIC is a 7 point scale that requires the clinician to assess how much the patient's pain has improved or worsened relative to a baseline state at the beginning of the intervention. and rated as: No change (or condition has gotten worse) (1) Almost the same, hardly any change at all (2) A little better, but no noticeable change (3) Somewhat better, but the change has not made any real difference (4) Moderately better, and a slight but noticeable change (5) Better and a definite improvement that has made a real and worthwhile difference (6) A great deal better and a considerable improvement that has made all the difference (7)improved This outcome is number of patients who chose a 5 or above on the PGIC 6 weeks after treatment.
Time Frame
6 weeks
Other Pre-specified Outcome Measures:
Title
Patients With Pain on Visual Analog Scale <4
Description
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). A higher score is associated with a higher level of pain. Number of patients showing a pain score of <4.
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bahman Jabbari, MD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale Physcian Building
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
30274305
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.
Results Reference
derived

Learn more about this trial

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

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