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NCT02002884 · ClinicalTrials.gov registry record · Phase 3
Dose-response Study of Efficacy and Safety of Botulinum Toxin Type A to Treat Spasticity of the Arm(s) or of Arm(s) and Leg(s) in Cerebral Palsy
A Phase 3 study, sponsored by Merz Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 351
- Enrollment target
NCT02002884: Completed Phase 3 study, sponsored by Merz Pharmaceuticals.
NCT02002884 is a Phase 3 study that has completed, run by Merz Pharmaceuticals. The registered enrollment target is 351 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (55% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02002884, a Phase 3 study, has completed, sponsored by Merz Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 351 participants
- Enrollment target
Study Summary
The purpose of this study is to determine whether injections of Botulinum toxin type A into muscles of one or both arms alone or in combination with injections into one or both legs are effective and safe in treating children/adolescents (age 2-17 years) with increased muscle tension/uncontrollable muscle stiffness (spasticity) due to cerebral palsy.
Primary Outcome
The AS categorizes severity of spasticity by judging resistance to passive movement. Spasticity was assessed by using the 5-point AS with:0 (no increase in tone); 1 (slight increase in tone giving a "catch" when the limb was moved in flexion or extension); 2 (more marked increase in tone, but limb easily flexed); 3 (considerable increase in tone -passive movements difficult); 4 (limb rigid in flexion or extension). Values represent least square (LS) mean differences between baseline and Week 4 r
Interventions
- DRUG IncobotulinumtoxinA (8 Units per kg body weight)
- DRUG IncobotulinumtoxinA (6 Units per kg body weight)
- DRUG IncobotulinumtoxinA (2 Units per kg body weight)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 351 participants |
| Start Date | 2014-03-28 |
| Est. Completion | 2018-08-28 |
| Phase | Phase 3 |
What the finished NCT02002884 record still lists
NCT02002884 is an interventional study that assigns participants to a tested intervention. The registered 351 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 (55% lower).
The record links to 0 conditions, and to 3 interventions - of which IncobotulinumtoxinA (8 Units per kg body weight) is the first listed.
NCT02002884 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02002884 about?
NCT02002884 is a clinical study titled "Dose-response Study of Efficacy and Safety of Botulinum Toxin Type A to Treat Spasticity of the Arm(s) or of Arm(s) and Leg(s) in Cerebral Palsy". The purpose of this study is to determine whether injections of Botulinum toxin type A into muscles of one or both arms alone or in combination with injections into one or both legs are effective and safe in treating children/adolescents (age 2-17 years) with increased muscle tension/uncontrollable ...
What is the current status of trial NCT02002884?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 351 participants. The study started on 2014-03-28. Estimated completion is 2018-08-28.
What interventions are being tested in trial NCT02002884?
The interventions under investigation include: IncobotulinumtoxinA (8 Units per kg body weight) (DRUG), IncobotulinumtoxinA (6 Units per kg body weight) (DRUG), IncobotulinumtoxinA (2 Units per kg body weight) (DRUG).
Who is sponsoring clinical trial NCT02002884?
This trial is sponsored by Merz Pharmaceuticals, which has 17 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02002884's enrollment target sits among peer trials
351 1033rd of 2000 higher than 967 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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