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NCT01486264 · ClinicalTrials.gov registry record · Phase 4
Open-Label Non-Inferiority Study Evaluating the Efficacy and Safety of Xeomin® in Subjects With Cervical Dystonia Flex
A Phase 4 study, sponsored by Merz Pharmaceuticals.
- Completed
- Registry status
- Phase 4
- Development phase
- 283
- Enrollment target
NCT01486264 is a Phase 4 study that has completed, run by Merz Pharmaceuticals. The registered enrollment target is 283 participants.
The verdict
NCT01486264, a Phase 4 study, has completed, sponsored by Merz Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 283 participants
- Enrollment target
Study Summary
This study will compare Xeomin®, a botulinum toxin medication, in shorter treatment intervals (Short Flex dosing) to the standard interval dosing (Long Flex dosing) to determine if the response to treatment is comparable in both how it works and any side effects. Xeomin® is approved by the United States Food and Drug Administration (FDA) for the treatment of cervical dystonia (CD). The use of Xeomin® is investigational in regards to shorter treatment intervals. An investigational use is one that is not approved by the FDA.
Interventions
- BIOLOGICAL Xeomin®
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 283 participants |
| Start Date | 2012-01-20 |
| Est. Completion | 2016-03-29 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01486264
The ClinicalTrials.gov registry entry for NCT01486264 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 283 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Merz Pharmaceuticals, which has 17 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Xeomin® is the first listed.
NCT01486264 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01486264 about?
NCT01486264 is a clinical study titled "Open-Label Non-Inferiority Study Evaluating the Efficacy and Safety of Xeomin® in Subjects With Cervical Dystonia Flex". This study will compare Xeomin®, a botulinum toxin medication, in shorter treatment intervals (Short Flex dosing) to the standard interval dosing (Long Flex dosing) to determine if the response to treatment is comparable in both how it works and any side effects. Xeomin® is approved by the United St...
What is the current status of trial NCT01486264?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 283 participants. The study started on 2012-01-20. Estimated completion is 2016-03-29.
What interventions are being tested in trial NCT01486264?
The interventions under investigation include: Xeomin® (BIOLOGICAL).
Who is sponsoring clinical trial NCT01486264?
This trial is sponsored by Merz Pharmaceuticals, which has 17 total clinical trials registered on ClinicalTrials.gov.
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