Study of Responsiveness of Seven Functional Tasks in Patients With Poststroke Upper Limb Spasticity With Botulinum Toxin Type A Treatment

Stroke Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00651690
• Other study ID #: 191622-065
• Status: Completed
• Phase: Phase 2
• First received: April 1, 2008
• Last updated: May 23, 2008
• Start date: March 2004
• Est. completion date: May 2005

Study information

• Verified date: May 2008
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: May 2005
• Est. primary completion date: May 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Medically stable poststroke with focal unilateral upper-limb spasticity

Exclusion Criteria:

• Stroke within 6 months of the study enrollment visit

• Previous or current botulinum toxin therapy of any type in the study limb

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Muscle Spasticity
• Stroke

Intervention

Biological:
• Botulinum Toxin Type A
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
• Placebo
Saline injection on Day 0

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Country where clinical trial is conducted

United States, 

References & Publications (3)

Turkel C, Bowen B, Liu J, Brin M. A pooled analysis of the safety of BoNT-A (BOTOX(R)) in the treatment of poststroke spasticity. Neurotox Res 2006 Apr;9(2-3):230 ABS-P25

Turkel 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

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Spasticity of the upper-limb flexors as measured by the Ashworth Scale		Week 6	No

External Links

•   Link to Clinical Trial Results