Restless Leg Syndrome
Conditions
Keywords
Restless Legs Syndrome, Leg pain, Sleep, Dysesthesias, incobotulinumtoxin
Brief 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.
Detailed description
Please contact the PI for details about the clinical study.
Interventions
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.
DRUGPlacebo
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.
Sponsors
Merz North America, Inc.
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Total Restless Leg Syndrome Rating Scale Score | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients Whose Patient Global Impression of Change (PGIC) Moderately or Much Improved | 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
| Measure | Time frame | Description |
|---|---|---|
| Patients With Pain on Visual Analog Scale <4 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Study Participants The subject may be randomly assigned to receive Placebo, saline
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. | 21 |
| Total | 21 |
Baseline characteristics
| Characteristic | All Study Participants |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 7 Participants |
| Age, Categorical Between 18 and 65 years | 14 Participants |
| Age, Continuous | 60.71 years STANDARD_DEVIATION 12.36 |
| Region of Enrollment United States | 21 participants |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 21 | 0 / 21 |
| serious Total, serious adverse events | 0 / 21 | 0 / 21 |
Outcome results
Primary
Mean Total Restless Leg Syndrome Rating Scale Score
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)
Time frame: 6 weeks
Population: Total RLS scale score was compared between incoA injections and and saline group injections.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Total Restless Leg Syndrome Rating Scale Score | 25.19 units on a scale | Standard Deviation 7.82 |
| Xeomin | Mean Total Restless Leg Syndrome Rating Scale Score | 19.46 units on a scale | Standard Deviation 9.41 |
Comparison: comparison of mean RLS Scale scores between 21 incoA and 21 saline injectionsp-value: 0.031t-test, 2 sided
Secondary
Number of Patients Whose Patient Global Impression of Change (PGIC) Moderately or Much Improved
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.
Time frame: 6 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Number of Patients Whose Patient Global Impression of Change (PGIC) Moderately or Much Improved | 3 participants |
| Xeomin | Number of Patients Whose Patient Global Impression of Change (PGIC) Moderately or Much Improved | 9 participants |
p-value: 0.0855Fisher Exact
Other Pre-specified
Patients With Pain on Visual Analog Scale <4
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.
Time frame: 6 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Patients With Pain on Visual Analog Scale <4 | 3 participants |
| Xeomin | Patients With Pain on Visual Analog Scale <4 | 12 participants |
p-value: 0.0088Fisher Exact