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 (PATTERN)
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
Sponsor: Merz Pharmaceuticals GmbH
A observational or N/A phase clinical study on Lower Limb or Combined Lower Limb and Upper Limb Spasticity Due to Stroke or Traumatic Brain Injury, this trial is ongoing. The trial is conducted by Merz Pharmaceuticals GmbH and has accumulated 74 data snapshots since 2019. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.
Status Flow
Change History
74 versions recorded-
Apr 28, 2026 — Present [daily]
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▶ Show 69 earlier versions
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First recorded
Eligibility 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.
Contact Information
- Merz Pharmaceuticals GmbH
For direct contact, visit the study record on ClinicalTrials.gov .
Study Locations
Aachen, Germany , Berlin, Germany , Bern, Switzerland , Birmingham, United States , Bonn, Germany , Brandenton, United States , Bratislava, Slovakia , Brno, Czechia , Brussels, Belgium , Brussels, Belgium and 61 more locations