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NCT01603602 · ClinicalTrials.gov registry record · Phase 3
BOTOX® Treatment in Pediatric Upper Limb Spasticity
A Phase 3 study, sponsored by Allergan.
- Completed
- Registry status
- Phase 3
- Development phase
- 235
- Enrollment target
NCT01603602: Completed Phase 3 study, sponsored by Allergan.
NCT01603602 is a Phase 3 study that has completed, run by Allergan. The registered enrollment target is 235 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01603602, a Phase 3 study, has completed, sponsored by Allergan.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 235 participants
- Enrollment target
Study Summary
This study will evaluate the safety and efficacy of BOTOX® (botulinum toxin Type A) in pediatric patients with upper limb spasticity.
Primary Outcome
The MAS-B was used to evaluate spasticity based on grading the resistance encountered in the principal muscle group (elbow and wrist) by means of passively moving a limb through its range of motion at a study specified velocity. The resistance encountered to passive stretch was graded using a 6-point scale where: 0=no increase in muscle tone (best) to 4=affected part(s) rigid in flexion or extension (worst). For analysis purposes, the MAS-B was recoded as follows: 0=1, 1=1, 1+=2, 2=3, 3=4, 4=5.
Interventions
- DRUG Normal Saline (Placebo)
- BIOLOGICAL botulinum toxin Type A
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 235 participants |
| Start Date | 2012-07-12 |
| Est. Completion | 2017-07-06 |
| Phase | Phase 3 |
What the finished NCT01603602 record still lists
NCT01603602 is an interventional study that assigns participants to a tested intervention. The registered 235 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 (70% lower).
The record links to 0 conditions, and to 2 interventions - of which Normal Saline (Placebo) is the first listed.
NCT01603602 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01603602 about?
NCT01603602 is a clinical study titled "BOTOX® Treatment in Pediatric Upper Limb Spasticity". This study will evaluate the safety and efficacy of BOTOX® (botulinum toxin Type A) in pediatric patients with upper limb spasticity.
What is the current status of trial NCT01603602?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 235 participants. The study started on 2012-07-12. Estimated completion is 2017-07-06.
What interventions are being tested in trial NCT01603602?
The interventions under investigation include: Normal Saline (Placebo) (DRUG), botulinum toxin Type A (BIOLOGICAL).
Who is sponsoring clinical trial NCT01603602?
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 NCT01603602's enrollment target sits among peer trials
235 1296th of 2000 higher than 704 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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