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| Name | Class |
|---|---|
| Merz North America, Inc. | INDUSTRY |
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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.
Please contact the PI for details about the clinical study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo , saline | Placebo Comparator | The subject may be randomly assigned to receive Placebo, saline |
|
| IncobotulinumtoxinA Treatment | Active Comparator | The subjects will be randomized to received injections of active study drug, incobotulinumtoxinA (Xeomin) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bahman Jabbari, MD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale Physcian Building | New Haven | Connecticut | 06510 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30274305 | Derived | Mittal SO, Machado D, Richardson D, Dubey D, Jabbari B. Botulinum Toxin in Restless Legs Syndrome-A Randomized Double-Blind Placebo-Controlled Crossover Study. Toxins (Basel). 2018 Sep 29;10(10):401. doi: 10.3390/toxins10100401. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo First, Then Incobotulinumtoxin A | 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. |
| FG001 | IncobotulinumtoxinA First, Then Placebo | The subjects will be randomized to received injections of active study drug, incobotulinumtoxinA (Xeomin) 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention |
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| Second Intervention (After 3 Months) |
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Cross over study. total 24 enrolled , 21 completed. The twenty one who competed the study had both saline and incobotulinum toxin injection ( crossover).
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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) | Total RLS scale score was compared between incoA injections and and saline group injections. | Posted | Mean | Standard Deviation | units on a scale | 6 weeks |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo , Saline | 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. |
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Relatively small number of participants. crossover not parallel design
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bahman Jabbari M.D. | Yale University School of Medicine | 203-737-2464 | bahman.jabbari@yale.edu |
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| ID | Term |
|---|---|
| D012148 | Restless Legs Syndrome |
| D010292 | Paresthesia |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
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| ID | Term |
|---|---|
| C545476 | incobotulinumtoxinA |
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| 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. |
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| 6 weeks |
| NOT COMPLETED |
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| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
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.
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|
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| 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. | Posted | Number | participants | 6 weeks |
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| 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. | Posted | Number | participants | 6 weeks |
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| 0 |
| 21 |
| 0 |
| 21 |
| EG001 | IncobotulinumtoxinA Treatment | The subjects will be randomized to received injections of active study drug, incobotulinumtoxinA (Xeomin) 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. | 0 | 21 | 0 | 21 |
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| D020447 |
| Parasomnias |
| D001523 | Mental Disorders |
| D020886 | Somatosensory Disorders |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |