# 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** · PHASE3 · ACTIVE_NOT_RECRUITING · sponsor: **Merz Pharmaceuticals GmbH** · enrollment: 603 (actual)

## Conditions studied

- Lower Limb or Combined Lower Limb and Upper Limb Spasticity Due to Stroke or Traumatic Brain Injury

## Interventions

- **DRUG:** NT 201
- **DRUG:** Placebo

## Key facts

- **NCT ID:** NCT03992404
- **Lead sponsor:** Merz Pharmaceuticals GmbH
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** ACTIVE_NOT_RECRUITING
- **Start date:** 2019-09-16
- **Primary completion:** 2025-06-19
- **Final completion:** 2027-04
- **Target enrollment:** 603 (ACTUAL)
- **Last updated:** 2026-04-23


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT03992404

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT03992404, "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". Retrieved via AI Analytics 2026-05-28 from https://api.ai-analytics.org/clinical/NCT03992404. Licensed CC0.

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