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NCT00564681 · ClinicalTrials.gov registry record · Phase 2
Study to Evaluate Safety, Efficacy of Botulinum Toxin Type A in Patients With Cervical Dystonia
A Phase 2 study, sponsored by Allergan.
- Completed
- Registry status
- Phase 2
- Development phase
- 242
- Enrollment target
NCT00564681: Completed Phase 2 study, sponsored by Allergan.
NCT00564681 is a Phase 2 study that has completed, run by Allergan. The registered enrollment target is 242 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (82% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00564681, a Phase 2 study, has completed, sponsored by Allergan.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 242 participants
- Enrollment target
Study Summary
Study is to investigate the use of the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) scale in a cervical dystonia population treated with botulinum toxin type A, and placebo.
Primary Outcome
Change from baseline in observed TWSTRS score at Week 4 of Treatment Cycle 1. The TWSTRS is an assessment scale used to measure the impact of cervical dystonia on patients. The score is comprised of 3 subscales: Severity, Disability, and Pain, each of which is scored independently. The total of these 3 comprises the TWSTRS total score which is scored from 0 (least symptoms) to 85 (worst symptoms). Higher scores indicate a greater degree of symptom severity. A negative change from baseline repres
Interventions
- DRUG Normal Saline
- BIOLOGICAL botulinum toxin type A
- BIOLOGICAL botulinum toxin type A Formulation 2
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 242 participants |
| Start Date | 2007-12 |
| Est. Completion | 2009-12 |
| Phase | Phase 2 |
What the finished NCT00564681 record still lists
NCT00564681 is an interventional study that assigns participants to a tested intervention. The registered 242 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (82% higher).
The record links to 0 conditions, and to 3 interventions - of which Normal Saline is the first listed.
NCT00564681 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00564681 about?
NCT00564681 is a clinical study titled "Study to Evaluate Safety, Efficacy of Botulinum Toxin Type A in Patients With Cervical Dystonia". Study is to investigate the use of the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) scale in a cervical dystonia population treated with botulinum toxin type A, and placebo.
What is the current status of trial NCT00564681?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 242 participants. The study started on 2007-12. Estimated completion is 2009-12.
What interventions are being tested in trial NCT00564681?
The interventions under investigation include: Normal Saline (DRUG), botulinum toxin type A (BIOLOGICAL), botulinum toxin type A Formulation 2 (BIOLOGICAL).
Who is sponsoring clinical trial NCT00564681?
This trial is sponsored by Allergan, which has 314 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00564681's enrollment target sits among peer trials
242 237th of 2000 higher than 1,762 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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