Phase 2
N=155
Safety Study of Botulinum Toxin Type A in Post-Upper Limb Stroke Patients With Reduced Lung Function
Stroke · Muscle Spasticity · Motor Neuron Disease
Bottom Line
View on ClinicalTrials.gov: NCT00076687 ↗Enrolled (actual)
155
Serious AEs
14.2%
Results posted
Oct 2011
Primary outcome: Primary: Change From Baseline in Forced Vital Capacity (FVC) — 2.889; 3.068; 2.923; 0.057 Liters of air
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- botulinum toxin Type A (Biological); saline (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Allergan
- Primary completion
- Aug 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Forced Vital Capacity (FVC) |
2.889; 3.068; 2.923; 0.057; 0.052; -0.081 | — |
| PRIMARY Change From Baseline in Forced Expiratory Volume (FEV1) |
2.111; 2.223; 2.168; 0.049; 0.023; -0.008 | — |
| SECONDARY Change From Baseline in FEV1/FVC Ratio |
0.741; 0.731; 0.742; 0.000; -0.006; 0.019 | — |
| SECONDARY Change From Baseline in Ashworth Scale |
3.19; 2.87; 2.96; -0.60; -1.01; -1.16 | — |
Summary
The purpose of this study is to evaluate the safety of injections of botulinum toxin Type A in patients with reduced lung function and focal upper limb poststroke spasticity
Eligibility Criteria
Inclusion Criteria
- Abnormal pulmonary function test results;
- focal, upper limb spasticity, upper motor neuron syndrome
Exclusion Criteria
- Previous exposure to botulinum toxin of any serotype
Data sourced from ClinicalTrials.gov (NCT00076687). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.