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NCT00407030 · ClinicalTrials.gov registry record · Phase 3
IncobotulinumtoxinA (Xeomin) Versus Placebo in the Treatment of Cervical Dystonia
A Phase 3 study of Cervical Dystonia, sponsored by Merz Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 233
- Enrollment target
- 1
- Study location
NCT00407030: Completed Phase 3 study of Cervical Dystonia, sponsored by Merz Pharmaceuticals.
NCT00407030 is a Phase 3 study of Cervical Dystonia that has completed, run by Merz Pharmaceuticals. The registered enrollment target is 233 participants, above the 72-participant average among 15 other Cervical Dystonia trials with a reported enrollment target (224% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00407030, a Phase 3 study of Cervical Dystonia, has completed, sponsored by Merz Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 233 participants
- Enrollment target
- 1
- Study location
Study Summary
At baseline patients received incobotulinumtoxinA (Xeomin) or placebo. Thereafter, all patients who entered the extension period were treated with up to five injection sessions of incobotulinumtoxinA (Xeomin) during the extension period.
Primary Outcome
The TWSTRS-Total score is the sum of scores of the three components of the scale: * TWSTRS-Severity score which ranges from 0 (=absence of severity) to 35 points (=maximum severity) * TWSTRS-Pain score which ranges from 0 (=no pain) to 20 (=maximum pain) * TWSTRS-Disability score which ranges from 0 (=no disability) to 30 (=maximum disability). The TWSTRS total score ranges from 0 (=best value) to 85 (=worst value). The change from baseline was calculated as the score at the corresponding visi
Conditions Studied
Interventions
- DRUG Placebo
- DRUG incobotulinumtoxinA (Xeomin) (240 Units)
- DRUG incobotulinumtoxinA (Xeomin) (120 Units)
Study Locations (1)
Texas
- - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 233 participants |
| Start Date | 2006-07 |
| Est. Completion | 2009-06 |
| Phase | Phase 3 |
What the finished NCT00407030 record still lists
NCT00407030 is an interventional study that assigns participants to a tested intervention. The registered 233 participants enrollment target is mid-sized for trials with a published cap, above the 72-participant average among 15 other Cervical Dystonia trials with a reported enrollment target (224% higher).
The record links to 1 condition, with Cervical Dystonia appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT00407030 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT00407030 about?
NCT00407030 is a clinical study titled "IncobotulinumtoxinA (Xeomin) Versus Placebo in the Treatment of Cervical Dystonia". At baseline patients received incobotulinumtoxinA (Xeomin) or placebo. Thereafter, all patients who entered the extension period were treated with up to five injection sessions of incobotulinumtoxinA (Xeomin) during the extension period.
What is the current status of trial NCT00407030?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 233 participants. The study started on 2006-07. Estimated completion is 2009-06.
What conditions does trial NCT00407030 study?
This clinical trial studies the following conditions: Cervical Dystonia.
What interventions are being tested in trial NCT00407030?
The interventions under investigation include: Placebo (DRUG), incobotulinumtoxinA (Xeomin) (240 Units) (DRUG), incobotulinumtoxinA (Xeomin) (120 Units) (DRUG).
Who is sponsoring clinical trial NCT00407030?
This trial is sponsored by Merz Pharmaceuticals, which has 17 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00407030 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00407030's enrollment target sits among peer trials
233 2nd of 15 the highest of 15 other Cervical Dystonia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cervical Dystonia 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.
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