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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 is a Phase 3 study that has completed, run by Merz Pharmaceuticals. The registered enrollment target is 351 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02002884
The ClinicalTrials.gov registry entry for NCT02002884 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 351 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Merz Pharmaceuticals, which has 17 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which IncobotulinumtoxinA (8 Units per kg body weight) is the first listed.
NCT02002884 reports 0 study locations.
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.
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