Clinical trial NCT01464307: Efficacy and Safety Study of Botulinum Toxin Type A Against Placebo to Treat Spasticity in the Leg After a Stroke
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Post-stroke Spasticity of the Lower Limb
Lead sponsor: Merz Pharmaceuticals GmbH
Sponsor class: INDUSTRY
First posted: 2011-11-03
Enrollment: 290
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Age from 18-80 yrs
* Lower limb spasticity
* Time since stroke greater than 3 months
* Need for 400 U Botulinum toxin type A

Exclusion Criteria:

* Body weight below 50kg
* Fixed contractures of the lower limb
* Generalized disorders of muscle activity like Myasthenia gravis that preclude use of Botulinum toxin type A
* Infection at the injection site

Primary outcomes:
measure: Change From Baseline in Ashworth Scale (AS) for Plantar Flexors at Week 4
timeFrame: Baseline and Week 4
measure: Co-primary Variable: Investigator's Global Assessment of Efficacy at Week 12
timeFrame: Baseline to Week 12
Secondary outcomes:
measure: Response Rate for Plantar Flexors at All Post-Baseline Visits for Subjects With an Improvement (Reduction) of at Least 1 Point From Baseline in the Ashworth Scale (AS)
timeFrame: Week 4, 8, and 12
measure: Ashworth Scale (AS) for Plantar Flexors at All Post-Baseline Visits
timeFrame: Baseline, Week 4, 8, and 12
Other outcomes:
Locations:
city: Downey
country: United States
facility: Merz Investigational Site #001184
state: California
city: Long Beach
country: United States
facility: Merz Investigational Site #001208
state: California
city: Fairfield
country: United States
facility: Merz Investigational Site #001244
state: Connecticut
city: Doral
country: United States
facility: Investigational site #001188
state: Florida
city: Overland Park
country: United States
facility: Merz Investigational Site # 001110
state: Kansas
city: Columbia
country: United States
facility: Merz Investigational Site #001209
state: Missouri
city: St. Louis
country: United States
facility: Merz Investigational Site #001210
state: Missouri
city: Stratford
country: United States
facility: Merz Investigational Site #001198
state: New Jersey
city: Plainview
country: United States
facility: Merz Investigational Site #001207
state: New York
city: Winston-Salem
country: United States
facility: Merz Investigational Site #001009
state: North Carolina
city: Nashville
country: United States
facility: Merz Investigational Site #001206
state: Tennessee
city: Houston
country: United States
facility: Merz Investigational Site #001183
state: Texas
city: Halifax
country: Canada
facility: Merz Investigational Site #001204
state: Nova Scotia
city: Winnipeg
country: Canada
facility: Merz Investigational Site #001202
city: Ostrava-Poruba
country: Czech Republic
facility: Merz Investigational Site #420024
city: Ostrava-Vitkovice
country: Czech Republic
facility: Merz Investigational Site #420031
city: Praha
country: Czech Republic
facility: Merz Investigational Site #420030
city: Rychnov nad Kneznou
country: Czech Republic
facility: Merz Investigational Site #420047
city: Garches
country: France
facility: Merz Investigational Site #033018
city: Rennes
country: France
facility: Merz Investigational Site #033024
city: Beelitz-Heilstätten
country: Germany
facility: Merz Investigational Site #049022
city: Düsseldorf
country: Germany
facility: Merz Investigational Site #049071
city: Hamburg
country: Germany
facility: Merz Investigational Site #049079
city: Kiel
country: Germany
facility: Merz Investigational Site #049304
city: München
country: Germany
facility: Merz Investigational Site #049072
city: München
country: Germany
facility: Merz Investigational Site #049148
city: Regensburg
country: Germany
facility: Merz Investigational Site #049303
city: Würzburg
country: Germany
facility: Merz Investigational Site #049302
city: Messina
country: Italy
facility: Merz Investigational Site #039006
city: Roma
country: Italy
facility: Merz Investigational Site #039011
city: Roma
country: Italy
facility: Merz Investigational Site #039012
city: Gdansk
country: Poland
facility: Merz Investigational Site #048057
city: Kielce
country: Poland
facility: Merz Investigational Site #048044
city: Krakow
country: Poland
facility: Merz Investigational Site #048080
city: Krakow
country: Poland
facility: Merz Investigational Site #048054
city: Krakow
country: Poland
facility: Merz Investigational Site #048031
city: Lodz
country: Poland
facility: Merz Investigational Site #048022
city: Lublin
country: Poland
facility: Merz Investigational Site #048051
city: Poznan
country: Poland
facility: Merz Investigational Site #048053
city: Poznan
country: Poland
facility: Merz Investigational Site #048081
city: Warszawa
country: Poland
facility: Merz Investigational Site #048055
city: Warszawa
country: Poland
facility: Merz Investigational Site #048023
city: Warszawa
country: Poland
facility: Merz Investigational Site #048056
city: Warszawa
country: Poland
facility: Merz Investigational Site #048033
city: Krasnoyarsk
country: Russian Federation
facility: Merz Investigational Site #007010
city: Moscow
country: Russian Federation
facility: Merz Investigational Site #007011
city: St. Petersburg
country: Russian Federation
facility: Merz Investigational Site #007009
city: Stavropol
country: Russian Federation
facility: Merz Investigational Site #007012
city: Madrid
country: Spain
facility: Merz Investigational Site #034027
city: Majadahonda
country: Spain
facility: Merz Investigational Site #034028
city: Sevilla
country: Spain
facility: Merz Investigational Site #034026
city: Sevilla
country: Spain
facility: Merz Investigational Site #034030
city: Terrassa
country: Spain
facility: Merz Investigational Site #034029
Study officials:
affiliation: Merz Pharmaceuticals GmbH
name: Medical Expert
role: STUDY_DIRECTOR
References: