Phase 4
N=274
BOTOX® Economic Spasticity Trial (BEST)
Muscle Spasticity
Bottom Line
View on ClinicalTrials.gov: NCT00549783 ↗Enrolled (actual)
274
Serious AEs
33.7%
Results posted
Aug 2012
Primary outcome: Primary: Physician Assessment of Success, as Determined by Percentage of Patients Who Achieve Their Principal Active Functional Goal at Week 24 — 40.9; 33.3 Percentage of Patients
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Botulinum Toxin Type A 900kD (Biological); Placebo (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Allergan
- Primary completion
- Jan 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Physician Assessment of Success, as Determined by Percentage of Patients Who Achieve Their Principal Active Functional Goal at Week 24 |
40.9; 33.3 | — |
| SECONDARY Physician Assessment of Success, as Determined by Percentage of Patients Who Achieve Their Principal Functional Goal at Week 12 |
33.1; 28.9 | — |
| SECONDARY Physician Assessment of Success, as Determined by Percentage of Patients Who Achieve Their Principal Functional Goal at Week 52 |
45.0; 52.4 | — |
| SECONDARY Patient Assessment of Success, as Determined by Percentage of Patients Who Achieve Their Principal Functional Goal at Week 12 |
33.1; 27.3 | — |
| SECONDARY Patient Assessment of Success, as Determined by Percentage of Patients Who Achieve Their Principal Functional Goal at Week 24 |
40.7; 39.0 | — |
| SECONDARY Patient Assessment of Success, as Determined by Percentage of Patients Who Achieve Their Principal Functional Goal at Week 52 |
48.9; 50.8 | — |
| SECONDARY Activities of Daily Living Quality of Life (QOL) Score at Week 12 |
48.81; 46.40; 51.16; 49.86 | — |
| SECONDARY Activities of Daily Living Quality of Life (QOL) Score at Week 24 |
48.81; 46.40; 52.34; 49.22 | — |
| SECONDARY Activities of Daily Living Quality of Life (QOL) Score at Week 52 |
48.81; 46.40; 51.90; 50.34 | — |
| SECONDARY Direct Costs for Canada |
18643; 13279 | — |
| SECONDARY Direct Costs for Germany |
10181; 10346 | — |
| SECONDARY Direct Costs for Sweden |
93916; 79580 | — |
| SECONDARY Direct Costs for the United Kingdom |
4671; 3977 | — |
Summary
This is a study to investigate if patients who have had a stroke and suffer from spasticity might benefit from being given BOTOX® in addition to the normal Standard Care. Spasticity is characterized by stiffness or frequent cramps accompanied by pain and abnormal movements and can prevent the carrying out of everyday tasks such as walking and getting dressed. BOTOX® is a neurotoxin, which is used to prevent the contraction of muscle fibre and has been shown to reduce spasticity significantly. Patients will be enrolled in this study at about 33 locations in Europe and Canada. Study participation will last for about 1 year.
Eligibility Criteria
Inclusion Criteria
- Patients with stroke due to a primary cerebral hemorrhage/infarction
- Subarachnoid hemorrhage producing an upper motor syndrome affecting one body side which results in a hemi-paralysis/plegia
Exclusion Criteria
- Patients with fixed contracture as a result of spasticity in the upper or lower limb planned to be treated and/or patients with other causes of spasticity (e.g. multiple sclerosis, spinal cord injury, etc.)
Data sourced from ClinicalTrials.gov (NCT00549783). 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.