Investigation of Efficacy of incobotulinumtoxinA (Xeomin) in Relieving Symptoms of Restless Leg Syndrome.
|Study Design:||Allocation: Randomized
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.|
- 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)
- 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.
- 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.
|Study Start Date:||September 2012|
|Study Completion Date:||August 2015|
|Primary Completion Date:||August 2015 (Final data collection date for primary outcome measure)|
Placebo Comparator: Placebo , saline
The subject may be randomly assigned to receive Placebo, saline
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)
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01931878
|United States, Connecticut|
|Yale Physcian Building|
|New Haven, Connecticut, United States, 06510|
|Principal Investigator:||Bahman Jabbari, MD||Yale University|