BOTOX® Economic Spasticity Trial (BEST)

Condition(s) targeted: Muscle Spasticity

Intervention: Botulinum Toxin Type A 900kD (Biological); Placebo (Biological)

Phase: Phase 4

Status: Recruiting

Sponsored by: Allergan

Official(s) and/or principal investigator(s):
Medical Director, Study Director, Affiliation: Allergan

Overall contact:
Allergan Inc, Email: clinicaltrials@allergan.com

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.

Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study

Primary outcome: Physician Assessment of Success, as determined by proportion of patients who achieve their principal functional goal

Secondary outcome:

Physician Assessment of Success, as determined by proportion of patients who achieve their principal functional goal

Patient Assessment of Success, as determined by proportion of patients who achieve their principal functional goal

Quality of Life and Activities of Daily Living

Resource Use

Minimum age: 18 Years. Maximum age: 85 Years. Gender(s): Both.

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.)

Allergan Inc, Email: clinicaltrials@allergan.com

Beelitz, 14547 Beelitz, Germany; Recruiting

Uppsala, 75185 Uppsala, Sweden; Recruiting

Edmonton, Alberta, Canada; Recruiting

Burslem, Stoke-on-Trent, United Kingdom; Recruiting

Starting date: October 2007
Ending date: June 2010
Last updated: September 19, 2008