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NCT01603615 · ClinicalTrials.gov registry record · Phase 3
BOTOX® Open-Label Treatment in Pediatric Upper Limb Spasticity
A Phase 3 study, sponsored by Allergan.
- Completed
- Registry status
- Phase 3
- Development phase
- 220
- Enrollment target
NCT01603615: Completed Phase 3 study, sponsored by Allergan.
NCT01603615 is a Phase 3 study that has completed, run by Allergan. The registered enrollment target is 220 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01603615, a Phase 3 study, has completed, sponsored by Allergan.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 220 participants
- Enrollment target
Study Summary
This study will evaluate the long-term safety of BOTOX® (botulinum toxin Type A) for the treatment of pediatric upper limb spasticity.
Primary Outcome
An adverse event (AE) was any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. A TEAE was an AE that occurred after receiving the first dose of investigational product or an AE present prior to first dose but increased in severity during the Treatment Period. Safety population included all treated participants.
Interventions
- BIOLOGICAL Botulinum Toxin Type A
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 220 participants |
| Start Date | 2012-10-30 |
| Est. Completion | 2018-09-03 |
| Phase | Phase 3 |
What the finished NCT01603615 record still lists
NCT01603615 is an interventional study that assigns participants to a tested intervention. The registered 220 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 (72% lower).
The record links to 0 conditions, and to 1 intervention - of which Botulinum Toxin Type A is the first listed.
NCT01603615 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01603615 about?
NCT01603615 is a clinical study titled "BOTOX® Open-Label Treatment in Pediatric Upper Limb Spasticity". This study will evaluate the long-term safety of BOTOX® (botulinum toxin Type A) for the treatment of pediatric upper limb spasticity.
What is the current status of trial NCT01603615?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 220 participants. The study started on 2012-10-30. Estimated completion is 2018-09-03.
What interventions are being tested in trial NCT01603615?
The interventions under investigation include: Botulinum Toxin Type A (BIOLOGICAL).
Who is sponsoring clinical trial NCT01603615?
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 NCT01603615's enrollment target sits among peer trials
220 1318th of 2000 higher than 672 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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