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Completed

NCT Number: NCT01931878

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

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.

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Key information

Conditions

Restless Leg Syndrome Dyssomnias Mental Disorders Nervous System Diseases Neurologic Manifestations Parasomnias Paresthesia Pathological Conditions, Signs and Symptoms Restless Legs Syndrome Sensation Disorders Signs and Symptoms Sleep Disorders, Intrinsic Sleep Wake Disorders Somatosensory Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Yale Physcian Building

New Haven, Connecticut, 06510, United States

About this study

Please contact the PI for details about the clinical study.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Xeomin

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.

Other names: Sterile saline water

Primary outcomes

  1. Mean Total Restless Leg Syndrome Rating Scale Score

    Time frame: 6 weeks

    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 outcomes

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

    Time frame: 6 weeks

    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 outcomes

  1. Patients With Pain on Visual Analog Scale <4

    Time frame: 6 weeks

    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.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • Merz North America, Inc.

Registry information

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Aug 29, 2013
Registry last updated
Mar 21, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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