BOTOX® Economic Spasticity Trial (BEST)

Allergan

Status and phase: Completed; Phase 4

Conditions: Muscle Spasticity

Treatments: Biological: Botulinum Toxin Type A 900kD; Biological: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00549783

AGN/HO/SPA/001-191622

Details and patient eligibility

About

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.

Enrollment: 274 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

274 participants in 2 patient groups, including a placebo group

Botulinum toxin type A 900kD

Active Comparator group

Description:

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.

Treatment:

Biological: Botulinum Toxin Type A 900kD

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Biological: Placebo