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Completed Phase 3 Interventional Results available

Efficacy and Safety Study of Botulinum Toxin Type A Against Placebo to Treat Spasticity in the Leg After a Stroke

ClinicalTrials.gov ID: NCT01464307

Public ClinicalTrials.gov record NCT01464307. 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.

ClinicalTrials.gov public records Last synced Oct 22, 2026, 10:49 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Prospective, Double-blind, Placebo-controlled, Randomized, Multi-center Study With an Open-label Extension Period to Investigate the Efficacy and Safety of NT 201 in the Treatment of Post-stroke Spasticity of the Lower Limb

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The purpose of this study is to determine whether injections of Botulinum toxin type A into muscles of the leg are effective in treating patients with increased muscle tension/uncontrollable muscle stiffness (spasticity) after a stroke.

Study identification

NCT ID
NCT01464307
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Merz Pharmaceuticals GmbH
Industry
Enrollment
290 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years to 80 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
Dec 2011 (Type not available)
Primary completion
Aug 2014 (Actual)
Completion
May 2015 (Actual)
Last update posted
Nov 7, 2016

2011 – 2015

United States locations

U.S. sites
12
U.S. states
10
U.S. cities
12
Facility City State ZIP Site status
Merz Investigational Site #001184 Downey California 90242 —
Merz Investigational Site #001208 Long Beach California 90806 —
Merz Investigational Site #001244 Fairfield Connecticut 06824 —
Investigational site #001188 Doral Florida 33172 —
Merz Investigational Site # 001110 Overland Park Kansas 66211 —
Merz Investigational Site #001209 Columbia Missouri 65212 —
Merz Investigational Site #001210 St Louis Missouri 63110 —
Merz Investigational Site #001198 Stratford New Jersey 08084 —
Merz Investigational Site #001207 Plainview New York 11803 —
Merz Investigational Site #001009 Winston-Salem North Carolina 27157 —
Merz Investigational Site #001206 Nashville Tennessee 37232 —
Merz Investigational Site #001183 Houston Texas 77030 —

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 41 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01464307, 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 Nov 7, 2016 · Synced Oct 22, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01464307 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →