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NCT01931878 · ClinicalTrials.gov registry record · Phase 2
Investigation of Efficacy of incobotulinumtoxinA (Xeomin) in Relieving Symptoms of Restless Leg Syndrome.
A Phase 2 study, sponsored by Yale University.
- Completed
- Registry status
- Phase 2
- Development phase
- 24
- Enrollment target
NCT01931878 is a Phase 2 study that has completed, run by Yale University. The registered enrollment target is 24 participants.
The verdict
NCT01931878, a Phase 2 study, has completed, sponsored by Yale University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 24 participants
- Enrollment target
Study 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.
Interventions
- DRUG Placebo
- DRUG incobotulinumtoxinA
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2012-09 |
| Est. Completion | 2015-08 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01931878
The ClinicalTrials.gov registry entry for NCT01931878 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Yale University, which has 1,492 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01931878 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01931878 about?
NCT01931878 is a clinical study titled "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 wil...
What is the current status of trial NCT01931878?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 24 participants. The study started on 2012-09. Estimated completion is 2015-08.
What interventions are being tested in trial NCT01931878?
The interventions under investigation include: Placebo (DRUG), incobotulinumtoxinA (DRUG).
Who is sponsoring clinical trial NCT01931878?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
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