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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
603
Active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins. Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl).
Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl).
Physical Medicine and Rehabilitation at University of Alabama at Birmingham; Merz investigational site #0010479
Birmingham, Alabama, United States
University of Arkansas for Medical Sciences, Merz investigational site #0010481
Little Rock, Arkansas, United States
Rancho Research Institute at Rancho Los Amigos National Rehabilitation Center; Merz investigational site #0010184
Downey, California, United States
New England institute for clinical research; Merz Investigational Site #0010441
Stamford, Connecticut, United States
Nova Clinical Research, Merz investigational site #0010474
Brandenton, Florida, United States
Change from baseline in derived Modified Ashworth Scale-Bohannon (MAS) ankle score (knee extended) at weeks 4 to 6
The MAS is a 6-grade scale
Time frame: Baseline to week 4-6
Co-Primary: Global Impression of Change Scale (GICS) assessed by physician at Week 4 to 6
The GICS s a 9-grade scale
Time frame: Week 4-6
Occurrence of treatment emergent adverse events [TEAEs] in the Main Period
Time frame: Baseline to week 12
Change from Study Baseline in Goal Attainment Scale [GAS] at Week 6
The GAS is a 6-grade scale
Time frame: Baseline to week 6
Global Impression of Change Scale (GICS) assessed by the study subject at Week 4 to 6
The GICS s a 9-grade scale
Time frame: Week 4-6
Global Impression of Change Scale (GICS) assessed by the caregiver at Week 4 to 6
The GICS s a 9-grade scale
Time frame: Week 4-6
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Brooks Rehabilitation Clinical Integration and Research, Merz investigational site #0010483
Jacksonville, Florida, United States
Sarasota Memorial Health Care System, Rehabilitation Medicine, Merz investigational site #0010478
Sarasota, Florida, United States
Neurology Center of New England P.C., Merz investigative site #0010476
Foxborough, Massachusetts, United States
Howard A. Rusk Rehabilitation Center; Merz investigational site #0010283
Columbia, Missouri, United States
Icahn School of Medicine at Mount Sinai, Neurology Department, Merz Investigational Site #0010191
New York, New York, United States
...and 61 more locations