Efficacy and Safety Study of Botulinum Toxin Type A Against Placebo to Treat Spasticity in the Leg After a Stroke
Public ClinicalTrials.gov record NCT01464307. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Prospective, Double-blind, Placebo-controlled, Randomized, Multi-center Study With an Open-label Extension Period to Investigate the Efficacy and Safety of NT 201 in the Treatment of Post-stroke Spasticity of the Lower Limb
Study identification
- NCT ID
- NCT01464307
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Merz Pharmaceuticals GmbH
- Industry
- Enrollment
- 290 participants
Conditions and interventions
Conditions
Interventions
- IncobotulinumtoxinA (400 Units) Drug
- Placebo Comparator Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years to 80 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 30, 2011
- Primary completion
- Jul 31, 2014
- Completion
- Apr 30, 2015
- Last update posted
- Nov 6, 2016
2011 – 2015
United States locations
- U.S. sites
- 12
- U.S. states
- 10
- U.S. cities
- 12
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Merz Investigational Site #001184 | Downey | California | 90242 | — |
| Merz Investigational Site #001208 | Long Beach | California | 90806 | — |
| Merz Investigational Site #001244 | Fairfield | Connecticut | 06824 | — |
| Investigational site #001188 | Doral | Florida | 33172 | — |
| Merz Investigational Site # 001110 | Overland Park | Kansas | 66211 | — |
| Merz Investigational Site #001209 | Columbia | Missouri | 65212 | — |
| Merz Investigational Site #001210 | St Louis | Missouri | 63110 | — |
| Merz Investigational Site #001198 | Stratford | New Jersey | 08084 | — |
| Merz Investigational Site #001207 | Plainview | New York | 11803 | — |
| Merz Investigational Site #001009 | Winston-Salem | North Carolina | 27157 | — |
| Merz Investigational Site #001206 | Nashville | Tennessee | 37232 | — |
| Merz Investigational Site #001183 | Houston | Texas | 77030 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 41 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01464307, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 6, 2016 · Synced Jul 22, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01464307 live on ClinicalTrials.gov.