Investigation of Efficacy of incobotulinumtoxinA (Xeomin) in Relieving Symptoms of Restless Leg Syndrome.
Condition: Restless Leg Syndrome
MeSH terms: Psychomotor Agitation; Restless Legs Syndrome; Syndrome
Intervention: incobotulinumtoxinA; Placebo
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.; 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 MeSH terms: incobotulinumtoxinA
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Restless Legs Syndrome; Leg pain; Sleep; Dysesthesias; incobotulinumtoxin

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.
    

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.