Trial record 15 of 26 for:    Open Studies | "Restless Legs Syndrome"

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

This study is currently recruiting participants.
Verified August 2013 by Yale University
Sponsor:
Collaborator:
Merz Pharmaceuticals, LLC
Information provided by (Responsible Party):
Bahman Jabbari, Yale University
ClinicalTrials.gov Identifier:
NCT01931878
First received: August 26, 2013
Last updated: NA
Last verified: August 2013
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Restless Leg Syndrome
Drug: incobotulinumtoxinA
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Investigation of Efficacy of incobotulinumtoxinA (Xeomin) in Relieving Symptoms of Restless Leg Syndrome.

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • Restless Leg Syndrome Rating Scale [ Time Frame: 24weeks ] [ Designated as safety issue: No ]
    The Restless Legs Syndrome Rating Scale is a questionaire consisting of ten questions to subjectively rate the severity of related symptoms to this condition.


Secondary Outcome Measures:
  • Epworth Sleep Scale [ Time Frame: 24weeks ] [ Designated as safety issue: No ]
    The Epworth Sleepiness Scale (EPS)is a set of 8 questions to evaluate daytime sleepiness.


Other Outcome Measures:
  • Restless Leg Syndrome Quality of Life questionnaire [ Time Frame: 24weeks ] [ Designated as safety issue: No ]
    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.

  • Visual Analog Scale [ Time Frame: 24weeks ] [ Designated as safety issue: No ]
    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).

  • Sleep Scale from the Medical Outcomes Study [ Time Frame: 24weeks ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 20
Study Start Date: September 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo vs. active Drug
The subject may be randomly assigned to receive Placebo va. active study drug incobotulinumtoxinA
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.
Other Name: Xeomin
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.
Other Name: Sterile saline water

Detailed Description:

Please contact the PI for details about the clinical study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01931878

Contacts
Contact: Bahman Jabbari, MD (203)499-9691 bahman.jabbari@yale.edu
Contact: Diana Richardson, MD (203) 737-1831 diana.richardson@yale.edu

Locations
United States, Connecticut
Yale Physcian Building Recruiting
New Haven, Connecticut, United States, 06510
Contact: Bahman Jabbari, MD    203-499-9691    bahman.jabbari@yale.edu   
Contact: Diana Richardson, MD    (203)737-1831    diana.richardson@yale.edu   
Principal Investigator: Bahman Jabbari, MD         
Sub-Investigator: Duarte Machado, MD         
Sub-Investigator: Diana Richardson, MD         
Sponsors and Collaborators
Yale University
Merz Pharmaceuticals, LLC
Investigators
Principal Investigator: Bahman Jabbari, MD Yale University
  More Information

No publications provided

Responsible Party: Bahman Jabbari, Principal Investigator, Yale University
ClinicalTrials.gov Identifier: NCT01931878     History of Changes
Other Study ID Numbers: 1206010332
Study First Received: August 26, 2013
Last Updated: August 26, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Yale University:
Restless Legs Syndrome
Leg pain
Sleep
Dysesthesias

Additional relevant MeSH terms:
Restless Legs Syndrome
Psychomotor Agitation
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Parasomnias
Mental Disorders
Dyskinesias
Neurologic Manifestations
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms
Botulinum Toxins, Type A
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 22, 2014