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NCT01392300 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety Study of Botulinum Toxin Type A Against Placebo to Treat Spasticity in the Arm After a Stroke
A Phase 3 study of Post-stroke Spasticity of the Upper Limb, sponsored by Merz Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 317
- Enrollment target
- 20
- Study locations
NCT01392300 is a Phase 3 study of Post-stroke Spasticity of the Upper Limb that has completed, run by Merz Pharmaceuticals. The registered enrollment target is 317 participants. The trial reports 20 study locations across 11 states.
The verdict
NCT01392300, a Phase 3 study of Post-stroke Spasticity of the Upper Limb, has completed, sponsored by Merz Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 317 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to determine whether injections of Botulinum toxin type A into muscles of the upper limb are effective in treating spasticity in patients after stroke.
Conditions Studied
Interventions
- DRUG Placebo Comparator
- DRUG IncobotulinumtoxinA (400 Units)
Study Locations (20)
Other
- Merz Investigational Site #420046 - Brno
- Merz Investigational Site #420029 - Brno
- Merz Investigational Site #420028 - Olomouc
- Merz Investigational Site #420024 - Ostrava-Poruba
- Merz Investigational Site #420025 - Pardubice
- Merz Investigational Site #420030 - Prague
- Merz Investigational Site #420045 - Prague
California
- Merz Investigational Site #001184 - Downey
- Merz Investigational Site #001017 - Fountain Valley
North Carolina
- Merz Investigational Site #001240 - Chapel Hill
- Merz Investigational Site #001009 - Winston-Salem
Pennsylvania
- Merz Investigational Site #001241 - Philadelphia
- Merz Investigational Site #001211 - Pittsburgh
Florida
- Merz Investigational Site #001188 - Miami
Georgia
- Merz Investigational Site #001037 - Augusta
Illinois
- Merz Investigational Site #001186 - Chicago
Kansas
- Merz Investigational Site # 001110 - Overland Park
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 317 participants |
| Start Date | 2011-09 |
| Est. Completion | 2014-02 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01392300
The ClinicalTrials.gov registry entry for NCT01392300 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 317 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 1 condition, with Post-stroke Spasticity of the Upper Limb appearing as the primary indexed condition, and to 2 interventions - of which Placebo Comparator is the first listed.
NCT01392300 reports 20 study locations spanning 11 distinct geographic areas - top geographies include Other, California, North Carolina.
Frequently Asked Questions
What is clinical trial NCT01392300 about?
NCT01392300 is a clinical study titled "Efficacy and Safety Study of Botulinum Toxin Type A Against Placebo to Treat Spasticity in the Arm After a Stroke". The purpose of this study is to determine whether injections of Botulinum toxin type A into muscles of the upper limb are effective in treating spasticity in patients after stroke.
What is the current status of trial NCT01392300?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 317 participants. The study started on 2011-09. Estimated completion is 2014-02.
What conditions does trial NCT01392300 study?
This clinical trial studies the following conditions: Post-stroke Spasticity of the Upper Limb.
What interventions are being tested in trial NCT01392300?
The interventions under investigation include: Placebo Comparator (DRUG), IncobotulinumtoxinA (400 Units) (DRUG).
Who is sponsoring clinical trial NCT01392300?
This trial is sponsored by Merz Pharmaceuticals, which has 17 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01392300 being conducted?
This trial has 20 study locations across California, Florida, Georgia, Illinois, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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