Clinical trial NCT00549783: BOTOX® Economic Spasticity Trial (BEST)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Muscle Spasticity
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2007-10-26
Enrollment: 274
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.)

Primary outcomes:
measure: Physician Assessment of Success, as Determined by Percentage of Patients Who Achieve Their Principal Active Functional Goal at Week 24
timeFrame: Week 24
Secondary outcomes:
measure: Physician Assessment of Success, as Determined by Percentage of Patients Who Achieve Their Principal Functional Goal at Week 12
timeFrame: Week 12
measure: Physician Assessment of Success, as Determined by Percentage of Patients Who Achieve Their Principal Functional Goal at Week 52
timeFrame: Week 52
measure: Patient Assessment of Success, as Determined by Percentage of Patients Who Achieve Their Principal Functional Goal at Week 12
timeFrame: Week 12
measure: Patient Assessment of Success, as Determined by Percentage of Patients Who Achieve Their Principal Functional Goal at Week 24
timeFrame: Week 24
measure: Patient Assessment of Success, as Determined by Percentage of Patients Who Achieve Their Principal Functional Goal at Week 52
timeFrame: Week 52
measure: Activities of Daily Living Quality of Life (QOL) Score at Week 12
timeFrame: Baseline, Week 12
measure: Activities of Daily Living Quality of Life (QOL) Score at Week 24
timeFrame: Baseline, Week 24
measure: Activities of Daily Living Quality of Life (QOL) Score at Week 52
timeFrame: Baseline, Week 52
measure: Direct Costs for Canada
timeFrame: 52 Weeks
measure: Direct Costs for Germany
timeFrame: 52 Weeks
measure: Direct Costs for Sweden
timeFrame: 52 Weeks
measure: Direct Costs for the United Kingdom
timeFrame: 52 Weeks
Other outcomes:
Locations:
city: Edmonton
country: Canada
state: Alberta
city: Beelitz
country: Germany
city: Uppsala
country: Sweden
city: Burslem
country: United Kingdom
state: Stoke-on-Trent
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Borg J, Ward AB, Wissel J, Kulkarni J, Sakel M, Ertzgaard P, Akerlund P, Reuter I, Herrmann C, Satkunam L, Wein T, Girod I, Wright N; BEST Study Group. Rationale and design of a multicentre, double-blind, prospective, randomized, European and Canadian study: evaluating patient outcomes and costs of managing adults with post-stroke focal spasticity. J Rehabil Med. 2011 Jan;43(1):15-22. doi: 10.2340/16501977-0663.