Study to Compare the Efficacy and Safety of NT 201 (Botulinum Toxin) With Placebo for the Treatment of Lower Limb Spasticity Caused by Stroke or Traumatic Brain Injury
Public ClinicalTrials.gov record NCT03992404. 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, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Investigate the Efficacy and Safety of NT 201 in the Treatment of Lower Limb Spasticity Caused by Stroke or Traumatic Brain Injury in Adult Subjects, Followed by an Open Label Extension With or Without Combined Upper Limb Treatment
Study identification
- NCT ID
- NCT03992404
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Merz Pharmaceuticals GmbH
- Industry
- Enrollment
- 603 participants
Conditions and interventions
Conditions
Interventions
- NT 201 Drug
- Placebo Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years to 85 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
- Sep 15, 2019
- Primary completion
- Jun 18, 2025
- Completion
- Mar 31, 2027
- Last update posted
- Jun 21, 2026
2019 – 2027
United States locations
- U.S. sites
- 15
- U.S. states
- 11
- U.S. cities
- 14
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Physical Medicine and Rehabilitation at University of Alabama at Birmingham; Merz investigational site #0010479 | Birmingham | Alabama | 35233 | — |
| University of Arkansas for Medical Sciences, Merz investigational site #0010481 | Little Rock | Arkansas | 72205 | — |
| Rancho Research Institute at Rancho Los Amigos National Rehabilitation Center; Merz investigational site #0010184 | Downey | California | 90242 | — |
| New England institute for clinical research; Merz Investigational Site #0010441 | Stamford | Connecticut | 06905 | — |
| Nova Clinical Research, Merz investigational site #0010474 | Bradenton | Florida | 34209 | — |
| Brooks Rehabilitation Clinical Integration and Research, Merz investigational site #0010483 | Jacksonville | Florida | 72204 | — |
| Sarasota Memorial Health Care System, Rehabilitation Medicine, Merz investigational site #0010478 | Sarasota | Florida | 34239 | — |
| Neurology Center of New England P.C., Merz investigative site #0010476 | Foxborough | Massachusetts | 02035 | — |
| Howard A. Rusk Rehabilitation Center; Merz investigational site #0010283 | Columbia | Missouri | 65203 | — |
| Icahn School of Medicine at Mount Sinai, Neurology Department, Merz Investigational Site #0010191 | New York | New York | 10029 | — |
| Weill Cornell Medical Center, Department of Rehabilitation Medicine; Merz Investigational Site #0010440 | New York | New York | 10065 | — |
| University of Pittsburgh Medical Center, Physical Medicine & Rehabiliation, Merz Investigational Site #0010211 | Pittsburgh | Pennsylvania | 15213 | — |
| UT Southwestern Medical Center, Department of Physical Medicine & Rehabilitation, Merz investigational site #0010082 | Dallas | Texas | 75390-9055 | — |
| University of Texas Health Science Center McGovern, Medical School Department of PM&R; merz investigational site #0010183 | Houston | Texas | 77030 | — |
| Medical College of Wisconsin,Department of PM&R, Merz Investigational Site #0010237 | Milwaukee | Wisconsin | 53226 | — |
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 56 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03992404, 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 Jun 21, 2026 · Synced Jul 22, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03992404 live on ClinicalTrials.gov.