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

This study has been completed.
Sponsor:
Collaborator:
Merz Pharmaceuticals, LLC
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT01931878
First received: August 26, 2013
Last updated: February 23, 2016
Last verified: February 2016
  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: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover 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:
  • Mean Total Restless Leg Syndrome Rating Scale Score [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

    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.



Other Outcome Measures:
  • Patients With Pain on Visual Analog Scale <4 [ Time Frame: 6 weeks ] [ 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). A higher score is associated with a higher level of pain. Number of patients showing a pain score of <4.


Enrollment: 24
Study Start Date: September 2012
Study Completion Date: August 2015
Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo , saline
The subject may be randomly assigned to receive Placebo, saline
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
Active Comparator: IncobotulinumtoxinA Treatment
The subjects will be randomized to received injections of active study drug, incobotulinumtoxinA (Xeomin)
Drug: 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.
Other Name: Xeomin

Detailed Description:
Please contact the PI for details about the clinical study.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01931878

Locations
United States, Connecticut
Yale Physcian Building
New Haven, Connecticut, United States, 06510
Sponsors and Collaborators
Yale University
Merz Pharmaceuticals, LLC
Investigators
Principal Investigator: Bahman Jabbari, MD Yale University
  More Information

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT01931878     History of Changes
Other Study ID Numbers: 1206010332 
Study First Received: August 26, 2013
Results First Received: September 4, 2015
Last Updated: February 23, 2016
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Syndrome
Psychomotor Agitation
Restless Legs Syndrome
Disease
Pathologic Processes
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Parasomnias
Mental Disorders
IncobotulinumtoxinA
Botulinum Toxins, Type A
AbobotulinumtoxinA
OnabotulinumtoxinA
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on July 28, 2016