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NCT01603459 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety Dose Titration Study of Botulinum Toxin Type A to Treat Spasticity in the Leg and Arm
A Phase 3 study, sponsored by Merz Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 155
- Enrollment target
NCT01603459: Completed Phase 3 study, sponsored by Merz Pharmaceuticals.
NCT01603459 is a Phase 3 study that has completed, run by Merz Pharmaceuticals. The registered enrollment target is 155 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01603459, a Phase 3 study, has completed, sponsored by Merz Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 155 participants
- Enrollment target
Study Summary
The purpose of this study is to determine whether injections with increasing doses (up to 800 units) of Botulinum toxin type A into muscles of the leg and/or arm are safe and effective in treating patients with spasticity on one body side due to cerebral causes.
Primary Outcome
Treatment-emergent Adverse Events (TEASs) are events observed from the time point of first injection until 16 weeks after last injection. Values reported here refer to the number of subjects affected.
Interventions
- DRUG IncobotulinumtoxinA
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 155 participants |
| Start Date | 2012-05 |
| Est. Completion | 2014-09 |
| Phase | Phase 3 |
What the finished NCT01603459 record still lists
NCT01603459 is an interventional study that assigns participants to a tested intervention. The registered 155 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 (80% lower).
The record links to 0 conditions, and to 1 intervention - of which IncobotulinumtoxinA is the first listed.
NCT01603459 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01603459 about?
NCT01603459 is a clinical study titled "Efficacy and Safety Dose Titration Study of Botulinum Toxin Type A to Treat Spasticity in the Leg and Arm". The purpose of this study is to determine whether injections with increasing doses (up to 800 units) of Botulinum toxin type A into muscles of the leg and/or arm are safe and effective in treating patients with spasticity on one body side due to cerebral causes.
What is the current status of trial NCT01603459?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 155 participants. The study started on 2012-05. Estimated completion is 2014-09.
What interventions are being tested in trial NCT01603459?
The interventions under investigation include: IncobotulinumtoxinA (DRUG).
Who is sponsoring clinical trial NCT01603459?
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 NCT01603459's enrollment target sits among peer trials
155 1509th of 2000 higher than 492 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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