NCT00549783

BOTOX® Economic Spasticity Trial (BEST)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 274 (actual)
• Sponsor: Allergan · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Muscle Spasticity

Interventions

Type	Name	Description
BIOLOGICAL	Botulinum Toxin Type A 900kD	The exact dosage and number of injection sites is based on the size, number, and location of muscles involved; the severity of spasticity; and the presence of local muscle weakness. First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit.
BIOLOGICAL	Placebo	The exact dosage and number of injection sites is based on the size, number, and location of muscles involved; the severity of spasticity; and the presence of local muscle weakness. First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit.

Timeline

• Start date: 2007-10-01
• Primary completion: 2010-01-01
• Completion: 2010-07-01
• First posted: 2007-10-26
• Last updated: 2012-08-22
• Results posted: 2012-08-22

Locations

4 sites across 4 countries: Canada, Germany, Sweden, United Kingdom