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NCT03992404 · ClinicalTrials.gov registry record · Phase 3
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
A Phase 3 study of Lower Limb or Combined Lower Limb and Upper Limb Spasticity Due to Stroke or Traumatic Brain Injury, sponsored by Merz Pharmaceuticals.
- Active
- Registry status
- Phase 3
- Development phase
- 603
- Enrollment target
- 20
- Study locations
NCT03992404: Active Phase 3 study of Lower Limb or Combined Lower Limb and Upper Limb Spasticity Due to Stroke or Traumatic Brain Injury, sponsored by Merz Pharmaceuticals.
NCT03992404 is a Phase 3 study of Lower Limb or Combined Lower Limb and Upper Limb Spasticity Due to Stroke or Traumatic Brain Injury that is active but no longer recruiting, run by Merz Pharmaceuticals. The registered enrollment target is 603 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (22% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03992404, a Phase 3 study of Lower Limb or Combined Lower Limb and Upper Limb Spasticity Due to Stroke or Traumatic Brain Injury, is active but no longer recruiting, sponsored by Merz Pharmaceuticals.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 603 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to determine whether a single treatment with administration of 400 Units NT 201 (botulinum toxin) is superior to placebo (no medicine) for the treatment of lower limb spasticity caused by stroke or traumatic brain injury (Main Period). Participants will be assigned to the treatment groups by chance and neither the participants nor the research staff who interact with them will know the allocation. The following 4 to 5 treatment cycles will investigate the safety and tolerability of treatment with NT 201 (botulinum toxin) when administered in doses between 400 and 800 Units (Open Label Extension Period). All participants will receive the treatment and the dose will depend on whether only lower limb spasticity or combined upper and lower limb spasticity are treated.
Primary Outcome
The MAS is a 6-grade scale
Conditions Studied
Interventions
- DRUG Placebo
- DRUG NT 201
Study Locations (20)
Other
- CHU Brugmann Neurology; Merz investigational site #0320015 - Brussels
- UCL Bruxelles, Physical Medicine & Rehabilitation Department, Merz Investigational Site #0320013 - Brussels
- UZ Leuven Pellenberg campus; Merz investigational site #0320014 - Pellenberg
- UCL Mont Godinne, Physical Medicine & Rehabilitation Department; Merz Investigational Site #0320008 - Yvoir
- Glenrose Rehabilitation Hospital, Merz investigational site #0010195 - Edmonton
Florida
- Nova Clinical Research, Merz investigational site #0010474 - Brandenton
- Brooks Rehabilitation Clinical Integration and Research, Merz investigational site #0010483 - Jacksonville
- Sarasota Memorial Health Care System, Rehabilitation Medicine, Merz investigational site #0010478 - Sarasota
New York
- Icahn School of Medicine at Mount Sinai, Neurology Department, Merz Investigational Site #0010191 - New York
- Weill Cornell Medical Center, Department of Rehabilitation Medicine; Merz Investigational Site #0010440 - New York
Texas
- UT Southwestern Medical Center, Department of Physical Medicine & Rehabilitation, Merz investigational site #0010082 - Dallas
- University of Texas Health Science Center McGovern, Medical School Department of PM&R; merz investigational site #0010183 - Houston
Alabama
- Physical Medicine and Rehabilitation at University of Alabama at Birmingham; Merz investigational site #0010479 - Birmingham
Arkansas
- University of Arkansas for Medical Sciences, Merz investigational site #0010481 - Little Rock
California
- Rancho Research Institute at Rancho Los Amigos National Rehabilitation Center; Merz investigational site #0010184 - Downey
Connecticut
- New England institute for clinical research; Merz Investigational Site #0010441 - Stamford
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 603 participants |
| Start Date | 2019-09-16 |
| Est. Completion | 2027-04 |
| Phase | Phase 3 |
What the registry record for NCT03992404 still lists
NCT03992404 is an interventional study that assigns participants to a tested intervention. The registered 603 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 (22% lower).
The record links to 1 condition, with Lower Limb or Combined Lower Limb and Upper Limb Spasticity Due to Stroke or Traumatic Brain Injury appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT03992404 names 20 study sites across 12 states, led by Other, Florida, New York.
Frequently Asked Questions
What is clinical trial NCT03992404 about?
NCT03992404 is a clinical study titled "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". The purpose of this study is to determine whether a single treatment with administration of 400 Units NT 201 (botulinum toxin) is superior to placebo (no medicine) for the treatment of lower limb spasticity caused by stroke or traumatic brain injury (Main Period). Participants will be assigned to th...
What is the current status of trial NCT03992404?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 603 participants. The study started on 2019-09-16. Estimated completion is 2027-04.
What conditions does trial NCT03992404 study?
This clinical trial studies the following conditions: Lower Limb or Combined Lower Limb and Upper Limb Spasticity Due to Stroke or Traumatic Brain Injury.
What interventions are being tested in trial NCT03992404?
The interventions under investigation include: Placebo (DRUG), NT 201 (DRUG).
Who is sponsoring clinical trial NCT03992404?
This trial is sponsored by Merz Pharmaceuticals, which has 17 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03992404 being conducted?
This trial has 20 study locations across Alabama, Arkansas, California, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03992404's enrollment target sits among peer trials
603 607th of 2000 higher than 1,394 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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