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NCT00496964 · ClinicalTrials.gov registry record · Phase 3
Botox for Non-surgical Lateral Release in Patellofemoral Pain
A Phase 3 study, sponsored by Virginia Commonwealth University.
- Terminated
- Registry status
- Phase 3
- Development phase
- 5
- Enrollment target
NCT00496964: Clinical Trial Phase 3 study, sponsored by Virginia Commonwealth University.
NCT00496964 is a Phase 3 study that was terminated before completion, run by Virginia Commonwealth University. The registered enrollment target is 5 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00496964, a Phase 3 study, was terminated before completion, sponsored by Virginia Commonwealth University.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 5 participants
- Enrollment target
Study Summary
The purpose of this study is to determine whether the use of botulinum toxin A injected into the lateral thigh muscle improves knee function and reduces knee pain secondary to patellofemoral syndrome. The study hypothesis is that botulinum toxin + specific exercises will be superior to specific exercises alone in improving knee function and reducing knee pain in individuals with patellofemoral syndrome.
Primary Outcome
Visual Analog Scale pain rating (VAS). 10 cm line with anchors at 0 (no pain) and 10 cm (worst imaginable pain). Scores are in cm (0 - 10) 0 no pain, higher values greater pain. Results given are for change at 12 weeks compared to baseline (week 12 score - baseline score)
Interventions
- DRUG Placebo
- DRUG Botulinum toxin A + exercise
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2005-05 |
| Est. Completion | 2008-06 |
| Phase | Phase 3 |
Why NCT00496964 stopped before completion
NCT00496964 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00496964 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00496964 about?
NCT00496964 is a clinical study titled "Botox for Non-surgical Lateral Release in Patellofemoral Pain". The purpose of this study is to determine whether the use of botulinum toxin A injected into the lateral thigh muscle improves knee function and reduces knee pain secondary to patellofemoral syndrome. The study hypothesis is that botulinum toxin + specific exercises will be superior to specific exer...
What is the current status of trial NCT00496964?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 5 participants. The study started on 2005-05. Estimated completion is 2008-06.
What interventions are being tested in trial NCT00496964?
The interventions under investigation include: Placebo (DRUG), Botulinum toxin A + exercise (DRUG).
Who is sponsoring clinical trial NCT00496964?
This trial is sponsored by Virginia Commonwealth University, which has 558 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00496964's enrollment target sits among peer trials
5 1997th of 2000 higher than 3 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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