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NCT01464307 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety Study of Botulinum Toxin Type A Against Placebo to Treat Spasticity in the Leg After a Stroke
A Phase 3 study, sponsored by Merz Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 290
- Enrollment target
NCT01464307: Completed Phase 3 study, sponsored by Merz Pharmaceuticals.
NCT01464307 is a Phase 3 study that has completed, run by Merz Pharmaceuticals. The registered enrollment target is 290 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01464307, a Phase 3 study, has completed, sponsored by Merz Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 290 participants
- Enrollment target
Study Summary
The purpose of this study is to determine whether injections of Botulinum toxin type A into muscles of the leg are effective in treating patients with increased muscle tension/uncontrollable muscle stiffness (spasticity) after a stroke.
Primary Outcome
The AS is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).
Interventions
- DRUG Placebo Comparator
- DRUG IncobotulinumtoxinA (400 Units)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 290 participants |
| Start Date | 2011-12 |
| Est. Completion | 2015-05 |
| Phase | Phase 3 |
What the finished NCT01464307 record still lists
NCT01464307 is an interventional study that assigns participants to a tested intervention. The registered 290 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 (62% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo Comparator is the first listed.
NCT01464307 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01464307 about?
NCT01464307 is a clinical study titled "Efficacy and Safety Study of Botulinum Toxin Type A Against Placebo to Treat Spasticity in the Leg After a Stroke". The purpose of this study is to determine whether injections of Botulinum toxin type A into muscles of the leg are effective in treating patients with increased muscle tension/uncontrollable muscle stiffness (spasticity) after a stroke.
What is the current status of trial NCT01464307?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 290 participants. The study started on 2011-12. Estimated completion is 2015-05.
What interventions are being tested in trial NCT01464307?
The interventions under investigation include: Placebo Comparator (DRUG), IncobotulinumtoxinA (400 Units) (DRUG).
Who is sponsoring clinical trial NCT01464307?
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 NCT01464307's enrollment target sits among peer trials
290 1171st of 2000 higher than 828 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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