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NCT00406367 · ClinicalTrials.gov registry record · Phase 3
IncobotulinumtoxinA (Xeomin) Versus Placebo in the Treatment of Blepharospasm
A Phase 3 study of Blepharospasm, sponsored by Merz Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 109
- Enrollment target
- 2
- Study locations
NCT00406367: Completed Phase 3 study of Blepharospasm, sponsored by Merz Pharmaceuticals.
NCT00406367 is a Phase 3 study of Blepharospasm that has completed, run by Merz Pharmaceuticals. The registered enrollment target is 109 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (86% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00406367, a Phase 3 study of Blepharospasm, has completed, sponsored by Merz Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 109 participants
- Enrollment target
- 2
- Study locations
Study Summary
Patients received one injection with incobotulinumtoxinA (Xeomin) or placebo at baseline. Thereafter, all patients who entered the Open-Label Extension Period (OLEX) received up to five injection sessions of incobotulinumtoxinA (Xeomin) during the OLEX period.
Primary Outcome
The Jankovic Rating Scale (JRS) is used for classification of the patient's individual symptoms of blepharospasm and for determination of the therapeutic efficacy of study medication. The JRS sumscore is the sum of the two components of the scale: * JRS-Severity score which ranges from 0 (=absence of severity) to 4 (=maximum severity) * JRS-Frequency score which ranges from 0 (=no frequency) to 4 (=maximum frequency) The change from baseline was calculated as the score at the corresponding visi
Conditions Studied
Interventions
- DRUG Placebo
- DRUG incobotulinumtoxinA (Xeomin)
Study Locations (2)
Texas
- Baylor College of Medicine - Houston
Nova Scotia
- David King, MD - Private Practice - Halifax
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 109 participants |
| Start Date | 2006-10 |
| Est. Completion | 2009-07 |
| Phase | Phase 3 |
What the finished NCT00406367 record still lists
NCT00406367 is an interventional study that assigns participants to a tested intervention. The registered 109 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (86% lower).
The record links to 1 condition, with Blepharospasm appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT00406367 reports a single indexed study location in Texas, Nova Scotia.
Frequently Asked Questions
What is clinical trial NCT00406367 about?
NCT00406367 is a clinical study titled "IncobotulinumtoxinA (Xeomin) Versus Placebo in the Treatment of Blepharospasm". Patients received one injection with incobotulinumtoxinA (Xeomin) or placebo at baseline. Thereafter, all patients who entered the Open-Label Extension Period (OLEX) received up to five injection sessions of incobotulinumtoxinA (Xeomin) during the OLEX period.
What is the current status of trial NCT00406367?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 109 participants. The study started on 2006-10. Estimated completion is 2009-07.
What conditions does trial NCT00406367 study?
This clinical trial studies the following conditions: Blepharospasm.
What interventions are being tested in trial NCT00406367?
The interventions under investigation include: Placebo (DRUG), incobotulinumtoxinA (Xeomin) (DRUG).
Who is sponsoring clinical trial NCT00406367?
This trial is sponsored by Merz Pharmaceuticals, which has 17 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00406367 being conducted?
This trial has 2 study locations across Texas, Nova Scotia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00406367's enrollment target sits among peer trials
109 1664th of 2000 higher than 337 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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