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Efficacy and Safety Study of Botulinum Toxin Type A Against Placebo to Treat Spasticity in the Arm After a Stroke
NCT01392300 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. 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 5 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01392300 reports 20 study locations spanning 11 distinct geographic areas — top geographies include Other, California, North Carolina. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01392300?
The interventions under investigation include: Placebo Comparator (DRUG), IncobotulinumtoxinA (400 Units) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01392300?
This trial is sponsored by Merz Pharmaceuticals, which has 5 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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