Study of Responsiveness of Seven Functional Tasks in Patients With Poststroke Upper Limb Spasticity With Botulinum Toxin Type A Treatment
1 other identifier
interventional
62
1 country
1
Brief Summary
This study evaluates the responsiveness of 7 functional tasks to botulinum toxin Type A treatment in poststroke patients with spasticity of the upper-limb flexors
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 stroke
Started Mar 2004
Shorter than P25 for phase_2 stroke
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2005
CompletedFirst Submitted
Initial submission to the registry
April 1, 2008
CompletedFirst Posted
Study publicly available on registry
April 3, 2008
CompletedMay 28, 2008
May 1, 2008
1.2 years
April 1, 2008
May 23, 2008
Conditions
Outcome Measures
Primary Outcomes (1)
Seven functional tasks (nail filing, hand cleaning, holding a water bottle, brushing teeth, holding a small fruit, holding a medium fruit, and holding a large fruit)
Week 6
Secondary Outcomes (1)
Spasticity of the upper-limb flexors as measured by the Ashworth Scale
Week 6
Study Arms (2)
1
EXPERIMENTALBotulinum Toxin Type A
2
PLACEBO COMPARATORSaline
Interventions
200 U to 360 U of botulinum toxin Type A on Day 0. Patients who met retreatment criteria received a second treatment (open-label) at Week 12 or Week 18
Eligibility Criteria
You may qualify if:
- Medically stable poststroke with focal unilateral upper-limb spasticity
You may not qualify if:
- Stroke within 6 months of the study enrollment visit
- Previous or current botulinum toxin therapy of any type in the study limb
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Allerganlead
Study Sites (1)
Unknown Facility
Indianapolis, Indiana, United States
Related Publications (2)
Turkel CC, Bowen B, Liu J, Brin MF. Pooled analysis of the safety of botulinum toxin type A in the treatment of poststroke spasticity. Arch Phys Med Rehabil. 2006 Jun;87(6):786-92. doi: 10.1016/j.apmr.2006.02.015.
PMID: 16731213BACKGROUNDTurkel C, Bowen B, Liu J, Brin M. A pooled analysis of the safety of BoNTA (BOTOX(R)) in the treatment of poststroke spasticity. Neurorehabil Neural Repair 2006;20(1):200 ABS-P3-081
BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Allergan
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
April 1, 2008
First Posted
April 3, 2008
Study Start
March 1, 2004
Primary Completion
May 1, 2005
Study Completion
May 1, 2005
Last Updated
May 28, 2008
Record last verified: 2008-05