BOTOX® Economic Spasticity Trial (BEST)

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 Overview

• Status: Completed
• Conditions: Muscle Spasticity
• Intervention / Treatment: Biological: Botulinum Toxin Type A 900kD; Biological: Placebo

• Study Type: Interventional
• Enrollment (Actual): 274
• Phase: Phase 4

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada
• Germany
  • Beelitz, Germany
• Sweden
  • Uppsala, Sweden
• United Kingdom
  • Stoke-on-Trent
    • Burslem, Stoke-on-Trent, United Kingdom

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Botulinum toxin type A 900kD; 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: 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.; Other Names: BOTOX®
Placebo Comparator: Placebo; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physician Assessment of Success, as Determined by Percentage of Patients Who Achieve Their Principal Active Functional Goal at Week 24	Physician assessment of success, as determined by percentage of patients who achieve their principal active functional goal (i.e. a score of 0 to +2 inclusive on the goal attainment scale [GAS]) at week 24 (or 10 weeks post second injection). The GAS is a 6-point scale where -3 means function is worse than at start, 0 means the expected goal was attained, and +2 is much better function than expected.	Week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physician Assessment of Success, as Determined by Percentage of Patients Who Achieve Their Principal Functional Goal at Week 12	Physician assessment of success, as determined by percentage of patients who achieve their principal functional goal (i.e., a score of 0 to +2 inclusive on the goal attainment scale [GAS]) at week 12. The GAS is 6-point scale where -3 means function is worse than at start, 0 means the expected goal was attained, and +2 is much better function than expected.	Week 12
Physician Assessment of Success, as Determined by Percentage of Patients Who Achieve Their Principal Functional Goal at Week 52	Physician assessment of success, as determined by percentage of patients who achieve their principal functional goal (i.e., a score of 0 to +2 inclusive on the goal attainment scale [GAS]) at week 52. The GAS is a 6-point scale where -3 means function is worse than at start, 0 means the expected goal was attained, and +2 is much better function than expected	Week 52
Patient Assessment of Success, as Determined by Percentage of Patients Who Achieve Their Principal Functional Goal at Week 12	Patient assessment of success, as determined by percentage of patients who achieve their principal functional goal (i.e., a score of 0 to +2 inclusive on the goal attainment scale [GAS]) at week 12. The GAS is a 6-point scale where -3 means function is worse than at start, 0 means the expected goal was attained, and +2 is much better function than expected.	Week 12
Patient Assessment of Success, as Determined by Percentage of Patients Who Achieve Their Principal Functional Goal at Week 24	Patient assessment of success, as determined by percentage of patients who achieve their principal functional goal (i.e., a score of 0 to +2 inclusive on the goal attainment scale [GAS]) at week 24 (or 10 weeks post second injection). The GAS is a 6-point scale where -3 means function is worse than at start, 0 means the expected goal was attained, and +2 is much better function than expected.	Week 24
Patient Assessment of Success, as Determined by Percentage of Patients Who Achieve Their Principal Functional Goal at Week 52	Patient assessment of success, as determined by percentage of patients who achieve their principal functional goal (i.e., a score of 0 to +2 inclusive on the goal attainment scale [GAS]) at week 52. The GAS is a 6-point scale where -3 means function is worse than at start, 0 means the expected goal was attained, and +2 is much better function than expected.	Week 52
Activities of Daily Living Quality of Life (QOL) Score at Week 12	Activities of Daily Living QOL score at week 12 as measured by SF-12 Physical Component (PCS-12). The SF-12 consists of 12 questions on various health questions. The PCS-12 is a sub-score calculated from the SF-12 total score based on the physical health questions where 0 is worse and 100 is best. A higher score indicates a better health state.	Baseline, Week 12
Activities of Daily Living Quality of Life (QOL) Score at Week 24	Activities of daily living QOL score at week 24 (or 10 weeks post second injection) as measured by SF-12 Physical Component (PCS-12). The SF-12 consists of 12 questions on various health questions. The PCS-12 is a sub-score calculated from the SF-12 total score based on the physical health questions where 0 is worse and 100 is best. A higher score indicates a better health state.	Baseline, Week 24
Activities of Daily Living Quality of Life (QOL) Score at Week 52	Activities of daily living QOL score at week 52 as measured by SF-12 Physical Component (PCS-12). The SF-12 consists of 12 questions on various health questions. The PCS-12 is a sub-score calculated from the SF-12 total score based on the physical health questions where 0 is worse and 100 is best. A higher score indicates a better health state.	Baseline, Week 52
Direct Costs for Canada	Direct healthcare costs associated with spasticity in cases where the primary reason for the use of the identified health care resource was the treatment of spasticity, or any related complications. Direct healthcare costs are presented in the local currency for Canada.	52 Weeks
Direct Costs for Germany	Direct healthcare costs associated with spasticity in cases where the primary reason for the use of the identified health care resource was the treatment of spasticity, or any related complications. Direct healthcare costs are presented in the local currency for Germany.	52 Weeks
Direct Costs for Sweden	Direct healthcare costs associated with spasticity in cases where the primary reason for the use of the identified health care resource was the treatment of spasticity, or any related complications. Direct healthcare costs are presented in the local currency for Sweden.	52 Weeks
Direct Costs for the United Kingdom	Direct healthcare costs associated with spasticity in cases where the primary reason for the use of the identified health care resource was the treatment of spasticity, or any related complications. Direct healthcare costs are presented in the local currency for the United Kingdom.	52 Weeks

Collaborators and Investigators

• Sponsor: Allergan

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2007
• Primary Completion (Actual): January 1, 2010
• Study Completion (Actual): July 1, 2010

Study Registration Dates

• First Submitted: October 24, 2007
• First Submitted That Met QC Criteria: October 25, 2007
• First Posted (Estimate): October 26, 2007

Study Record Updates

• Last Update Posted (Estimate): August 22, 2012
• Last Update Submitted That Met QC Criteria: July 18, 2012
• Last Verified: July 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Muscle Hypertonia; Muscle Spasticity; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Cholinergic Agents; Membrane Transport Modulators; Acetylcholine Release Inhibitors; Neuromuscular Agents; Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
• Other Study ID Numbers: AGN/HO/SPA/001-191622