Muscle Spasticity, Stroke
Conditions
Brief summary
The purpose of this study is to evaluate the safety of repeated doses of Botulinum Toxin Type A for the treatment of focal upper limb poststroke spasticity
Interventions
BIOLOGICALBotulinum Toxin Type A
Each patient received from 1 to 5 treatments, with a minimum of 12 weeks between treatments. For each treatment, a total dose of 200 U to 400 U botulinum toxin Type A was injected into the wrist and finger flexor muscles of the affected upper limb, not to exceed 6 U/kg
Sponsors
Allergan
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Medically stable poststroke patients with spastic muscles in the upper limb
Exclusion criteria
* Stroke within 6 months of study enrollment * Previous therapy with Botulinum Toxin Type A for treatment of any condition prior to 4 months of enrollment, for treatment of any condition prior to 01 January 1998
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events | Week 54 |
Secondary
| Measure | Time frame |
|---|---|
| Spasticity as measured by the Ashworth scale | Week 54 |
Countries
Canada, United States
Outcome results
None listed