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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
NCT03992404 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03992404
The ClinicalTrials.gov registry entry for NCT03992404 describes a study currently listed as active not recruiting. 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 603 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 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. 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: NCT03992404 reports 20 study locations spanning 12 distinct geographic areas — top geographies include Other, Florida, New York. 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 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03992404?
The interventions under investigation include: Placebo (DRUG), NT 201 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03992404?
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 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.
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