Clinical trial NCT01392300: Efficacy and Safety Study of Botulinum Toxin Type A Against Placebo to Treat Spasticity in the Arm 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 Upper Limb
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Post-stroke Spasticity of the Upper Limb
Lead sponsor: Merz Pharmaceuticals GmbH
Sponsor class: INDUSTRY
First posted: 2011-07-12
Enrollment: 317
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 upper limb are effective in treating spasticity in patients after stroke.

Detailed description: The study consists of a randomized, double-blind, placebo-controlled, parallel-group, single-dose main period followed by an open-label, non-controlled, repeated-dose extension period (Open-Label Extension Period - OLEX).

Eligibility criteria: Inclusion Criteria:

* Upper 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 upper 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) Score of Primary Target Clinical Pattern
timeFrame: Week 4
measure: Investigator's Global Impression of Change
timeFrame: Week 4
Secondary outcomes:
measure: Response Rates on the Ashworth Scale at Week 4 Calculated for the Primary Target Clinical Pattern
timeFrame: Week 4
measure: Response Rates on the Ashworth Scale at Week 8 Calculated for the Primary Target Clinical Pattern
timeFrame: Week 8
measure: Response Rates on the Ashworth Scale at Week 12 Calculated for the Primary Target Clinical Pattern
timeFrame: Week 12
measure: Response Rates on the Ashworth Scale at Week 4 Calculated for the Muscle Group Flexed Wrist
timeFrame: Week 4
measure: Response Rates on the Ashworth Scale at Week 8 Calculated for the Muscle Group Flexed Wrist
timeFrame: Week 8
measure: Response Rates on the Ashworth Scale at Week 12 Calculated for the Muscle Group Flexed Wrist
timeFrame: Week 12
measure: Response Rates on the Ashworth Scale at Week 4 Calculated for the Muscle Group Flexed Elbow
timeFrame: Week 4
measure: Response Rates on the Ashworth Scale at Week 8 Calculated for the Muscle Group Flexed Elbow
timeFrame: Week 8
measure: Response Rates on the Ashworth Scale at Week 12 Calculated for the Muscle Group Flexed Elbow
timeFrame: Week 12
measure: Response Rates on the Ashworth Scale at Week 4 Calculated for the Muscle Group Clenched Fist
timeFrame: Week 4
measure: Response Rates on the Ashworth Scale at Week 8 Calculated for the Muscle Group Clenched Fist
timeFrame: Week 8
measure: Response Rates on the Ashworth Scale at Week 12 Calculated for the Muscle Group Clenched Fist
timeFrame: Week 12
measure: Response Rates on the Ashworth Scale at Week 4 Calculated for the Muscle Group Thumb-in-palm
timeFrame: Week 4
measure: Response Rates on the Ashworth Scale at Week 8 Calculated for the Muscle Group Thumb-in-palm
timeFrame: Week 8
measure: Response Rates on the Ashworth Scale at Week 12 Calculated for the Muscle Group Thumb-in-palm
timeFrame: Week 12
measure: Response Rates on the Ashworth Scale at Week 4 Calculated for the Muscle Group Pronated Forearm
timeFrame: Week 4
measure: Response Rates on the Ashworth Scale at Week 8 Calculated for the Muscle Group Pronated Forearm
timeFrame: Week 8
measure: Response Rates on the Ashworth Scale at Week 12 Calculated for the Muscle Group Pronated Forearm
timeFrame: Week 12
measure: Changes From Baseline to Week 4 in Ashworth Scale Score for Treated Muscle Group Flexed Wrist.
timeFrame: Week 4
measure: Changes From Baseline to Week 8 in Ashworth Scale Score for Treated Muscle Group Flexed Wrist.
timeFrame: Week 8
measure: Changes From Baseline to Week 12 in Ashworth Scale Score for Treated Muscle Group Flexed Wrist.
timeFrame: Week 12
measure: Changes From Baseline to Week 4 in Ashworth Scale Score for Treated Muscle Group Flexed Elbow.
timeFrame: Week 4
measure: Changes From Baseline to Week 8 in Ashworth Scale Score for Treated Muscle Group Flexed Elbow.
timeFrame: Week 8
measure: Changes From Baseline to Week 12 in Ashworth Scale Score for Treated Muscle Group Flexed Elbow.
timeFrame: Week 12
measure: Changes From Baseline to Week 4 in Ashworth Scale Score for Treated Muscle Group Clenched Fist.
timeFrame: Week 4
measure: Changes From Baseline to Week 8 in Ashworth Scale Score for Treated Muscle Group Clenched Fist.
timeFrame: Week 8
measure: Changes From Baseline to Week 12 in Ashworth Scale Score for Treated Muscle Group Clenched Fist.
timeFrame: Week 12
measure: Changes From Baseline to Week 4 in Ashworth Scale Score for Treated Muscle Group Thumb-in-palm.
timeFrame: Week 4
measure: Changes From Baseline to Week 8 in Ashworth Scale Score for Treated Muscle Group Thumb-in-palm.
timeFrame: Week 8
measure: Changes From Baseline to Week 12 in Ashworth Scale Score for Treated Muscle Group Thumb-in-palm.
timeFrame: Week 12
measure: Changes From Baseline to Week 4 in Ashworth Scale Score for Treated Muscle Group Pronated Forearm.
timeFrame: Week 4
measure: Changes From Baseline to Week 8 in Ashworth Scale Score for Treated Muscle Group Pronated Forearm.
timeFrame: Week 8
measure: Changes From Baseline to Week 12 in Ashworth Scale Score for Treated Muscle Group Pronated Forearm.
timeFrame: Week 12
measure: Changes From Baseline to Week 4 in Disability Assessment Scale - Principal Therapeutic Target Domain
timeFrame: Week 4
measure: Changes From Baseline to Week 8 in Disability Assessment Scale - Principal Therapeutic Target Domain
timeFrame: Week 8
measure: Changes From Baseline to Week 12 in Disability Assessment Scale - Principal Therapeutic Target Domain
timeFrame: Week 12
measure: Changes From Baseline to Week 4 in Disability Assessment Scale - Domain Hygiene
timeFrame: Week 4
measure: Changes From Baseline to Week 8 in Disability Assessment Scale - Domain Hygiene
timeFrame: Week 8
measure: Changes From Baseline to Week 12 in Disability Assessment Scale - Domain Hygiene
timeFrame: Week 12
measure: Changes From Baseline to Week 4 in Disability Assessment Scale - Domain Dressing
timeFrame: Week 4
measure: Changes From Baseline to Week 8 in Disability Assessment Scale - Domain Dressing
timeFrame: Week 8
measure: Changes From Baseline to Week 12 in Disability Assessment Scale - Domain Dressing
timeFrame: Week 12
measure: Changes From Baseline to Week 4 in Disability Assessment Scale - Domain Limb Position
timeFrame: Week 4
measure: Changes From Baseline to Week 8 in Disability Assessment Scale - Domain Limb Position
timeFrame: Week 8
measure: Changes From Baseline to Week 12 in Disability Assessment Scale - Domain Limb Position
timeFrame: Week 12
measure: Changes From Baseline to Week 4 in Disability Assessment Scale - Domain Pain
timeFrame: Week 4
measure: Changes From Baseline to Week 8 in Disability Assessment Scale - Domain Pain
timeFrame: Week 8
measure: Changes From Baseline to Week 12 in Disability Assessment Scale - Domain Pain
timeFrame: Week 12
Other outcomes:
Locations:
city: Downey
country: United States
facility: Merz Investigational Site #001184
state: California
city: Fountain Valley
country: United States
facility: Merz Investigational Site #001017
state: California
city: Miami
country: United States
facility: Merz Investigational Site #001188
state: Florida
city: Augusta
country: United States
facility: Merz Investigational Site #001037
state: Georgia
city: Chicago
country: United States
facility: Merz Investigational Site #001186
state: Illinois
city: Overland Park
country: United States
facility: Merz Investigational Site # 001110
state: Kansas
city: Stratford
country: United States
facility: Merz Investigational Site #001198
state: New Jersey
city: Chapel Hill
country: United States
facility: Merz Investigational Site #001240
state: North Carolina
city: Winston-Salem
country: United States
facility: Merz Investigational Site #001009
state: North Carolina
city: Philadelphia
country: United States
facility: Merz Investigational Site #001241
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Merz Investigational Site #001211
state: Pennsylvania
city: Chattanooga
country: United States
facility: Merz Investigational Site #001245
state: Tennessee
city: Houston
country: United States
facility: Merz Investigational Site #001226
state: Texas
city: Brno
country: Czech Republic
facility: Merz Investigational Site #420046
city: Brno
country: Czech Republic
facility: Merz Investigational Site #420029
city: Olomouc
country: Czech Republic
facility: Merz Investigational Site #420028
city: Ostrava-Poruba
country: Czech Republic
facility: Merz Investigational Site #420024
city: Pardubice
country: Czech Republic
facility: Merz Investigational Site #420025
city: Praha
country: Czech Republic
facility: Merz Investigational Site #420030
city: Praha
country: Czech Republic
facility: Merz Investigational Site #420045
city: Rychnov nad Kneznou
country: Czech Republic
facility: Merz Investigational Site #420047
city: Rostock
country: Germany
facility: Merz Investigational Site #049134
city: Budapest
country: Hungary
facility: Merz Investigational Site #036004
city: Budapest
country: Hungary
facility: Merz Investigational Site # 036009
city: Nyiregyhaza
country: Hungary
facility: Merz Investigational Site #036005
city: Szeged
country: Hungary
facility: Merz Investigational Site #036008
city: Porur
country: India
facility: Merz Investigational Site #091003
state: Chennai
city: Bangalore
country: India
facility: Merz Investigational Site #091006
state: Karnataka
city: Trivandrum
country: India
facility: Merz Investigational Site #091002
state: Kerala
city: Chennai
country: India
facility: Merz Investigational Site #091007
state: Tamil Nadu
city: Coimbatore
country: India
facility: Merz Investigational Site #091008
state: Tamil Nadu
city: Lucknow
country: India
facility: Merz Investigational Site #091001
state: Uttar Pradesh
city: New Delhi
country: India
facility: Merz Investigational Site #091004
city: Gdansk
country: Poland
facility: Merz Investigational Site # 048029
city: Kielce
country: Poland
facility: Merz Investigational Site #048044
city: Krakow
country: Poland
facility: Merz Investigational Site #048031
city: Lodz
country: Poland
facility: Merz Investigational Site #048050
city: Lublin
country: Poland
facility: Merz Investigational Site #048051
city: Olsztyn
country: Poland
facility: Merz Investigational Site #048032
city: Poznan
country: Poland
facility: Merz Investigational Site #048053
city: Warszawa
country: Poland
facility: Merz Investigational Site #048023
city: Warszawa
country: Poland
facility: Merz Investigational Site #048052
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 #007005
Study officials:
affiliation: Merz Pharmaceuticals GmbH
name: Medical Expert
role: STUDY_DIRECTOR
References:
citation: Elovic EP, Munin MC, Kanovsky P, Hanschmann A, Hiersemenzel R, Marciniak C. Randomized, placebo-controlled trial of incobotulinumtoxina for upper-limb post-stroke spasticity. Muscle Nerve. 2016 Mar;53(3):415-21. doi: 10.1002/mus.24776. Epub 2015 Dec 15.
citation: Marciniak C, Munin MC, Brashear A, Rubin BS, Patel AT, Slawek J, Hanschmann A, Hiersemenzel R, Elovic EP. IncobotulinumtoxinA Treatment in Upper-Limb Poststroke Spasticity in the Open-Label Extension Period of PURE: Efficacy in Passive Function, Caregiver Burden, and Quality of Life. PM R. 2020 May;12(5):491-499. doi: 10.1002/pmrj.12265. Epub 2020 Jan 22.
citation: Marciniak C, Munin MC, Brashear A, Rubin BS, Patel AT, Slawek J, Hanschmann A, Hiersemenzel R, Elovic EP. IncobotulinumtoxinA Efficacy and Safety in Adults with Upper-Limb Spasticity Following Stroke: Results from the Open-Label Extension Period of a Phase 3 Study. Adv Ther. 2019 Jan;36(1):187-199. doi: 10.1007/s12325-018-0833-7. Epub 2018 Nov 27.