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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: Completed Phase 4 study, sponsored by Merz Pharmaceuticals.
NCT01486264 is a Phase 4 study that has completed, run by Merz Pharmaceuticals. The registered enrollment target is 283 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (45% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The validated assessment scale TWSTRS was used to measure the impact of cervical dystonia (CD) on participants. A blinded rater performed all TWSTRS-Severity subscale assessments for a given participant. TWSTRS-Severity subscale score ranges from 0 (=absence of severity) to 35 points (=maximum severity).
Interventions
- BIOLOGICAL Xeomin®
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 283 participants |
| Start Date | 2012-01-20 |
| Est. Completion | 2016-03-29 |
| Phase | Phase 4 |
What the finished NCT01486264 record still lists
NCT01486264 is an interventional study that assigns participants to a tested intervention. The registered 283 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (45% lower).
The record links to 0 conditions, and to 1 intervention - of which Xeomin® is the first listed.
NCT01486264 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01486264's enrollment target sits among peer trials
283 303rd of 2000 higher than 1,698 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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