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NCT02221648 · ClinicalTrials.gov registry record · Phase 2
Investigation of Efficacy of Botulinum Toxin A (Dysport) in Chronic Low Back Pain
A Phase 2 study, sponsored by Yale University.
- Terminated
- Registry status
- Phase 2
- Development phase
- 43
- Enrollment target
NCT02221648: Clinical Trial Phase 2 study, sponsored by Yale University.
NCT02221648 is a Phase 2 study that was terminated before completion, run by Yale University. The registered enrollment target is 43 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (68% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02221648, a Phase 2 study, was terminated before completion, sponsored by Yale University.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 43 participants
- Enrollment target
Study Summary
The scientific aim of this study is to investigate the efficacy of abobotulinumtoxinA (Dysport - Ipsen Pharmaceuticals) in chronic low back pain. The investigators hypothesis is that injection of Dysport brand of botulinum toxin type A into erector spinae muscles (extensors of the spine) can relieve low back pain through anti-spasm and analgesic effect of botulinum toxin.
Primary Outcome
The primary outcome measure in this protocol is the proportion of subjects that have VAS \<4 (patients with no or mild pain) at week 6. The pain VAS is a continuous scale comprised of a line 10 centimeters in length, anchored by 2 verbal descriptors, one for each symptom extreme. For pain intensity, the scale is anchored by "no pain" (score of 0) and "worst imaginable pain" (score of 10).
Interventions
- DRUG Placebo
- DRUG AbobotulinumtoxinA Treatment
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2012-12 |
| Est. Completion | 2015-09 |
| Phase | Phase 2 |
Why NCT02221648 stopped before completion
NCT02221648 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 43 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (68% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02221648 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02221648 about?
NCT02221648 is a clinical study titled "Investigation of Efficacy of Botulinum Toxin A (Dysport) in Chronic Low Back Pain". The scientific aim of this study is to investigate the efficacy of abobotulinumtoxinA (Dysport - Ipsen Pharmaceuticals) in chronic low back pain. The investigators hypothesis is that injection of Dysport brand of botulinum toxin type A into erector spinae muscles (extensors of the spine) can reliev...
What is the current status of trial NCT02221648?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 43 participants. The study started on 2012-12. Estimated completion is 2015-09.
What interventions are being tested in trial NCT02221648?
The interventions under investigation include: Placebo (DRUG), AbobotulinumtoxinA Treatment (DRUG).
Who is sponsoring clinical trial NCT02221648?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02221648's enrollment target sits among peer trials
43 1332nd of 2000 higher than 662 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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