BOTOX® Economic Spasticity Trial (BEST) - Full Text View

Sponsor:	Allergan
Information provided by:	Allergan
ClinicalTrials.gov Identifier:	NCT00549783

Purpose

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.

Condition	Intervention	Phase
Muscle Spasticity	Biological: Botulinum Toxin Type A 900kD Biological: Placebo	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Botox

Drug Information available for: Botulinum toxin A Clostridium botulinum toxin

U.S. FDA Resources

Further study details as provided by Allergan:

Primary Outcome Measures:

Physician Assessment of Success, as determined by proportion of patients who achieve their principal functional goal [ Time Frame: Week 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Physician Assessment of Success, as determined by proportion of patients who achieve their principal functional goal [ Time Frame: Week 12, Week 52 ] [ Designated as safety issue: No ]
Patient Assessment of Success, as determined by proportion of patients who achieve their principal functional goal [ Time Frame: Week 12, Week 24, Week 52 ] [ Designated as safety issue: No ]
Quality of Life and Activities of Daily Living [ Time Frame: Baseline, Week 12, Week 24, Week 52 ] [ Designated as safety issue: No ]
Resource Use [ Time Frame: Baseline to Week 52 ] [ Designated as safety issue: No ]

Enrollment:	274
Study Start Date:	October 2007
Study Completion Date:	July 2010
Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1 Botulinum toxin type A	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 Name: BOTOX®
Placebo Comparator: 2 Placebo	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.

Arms

Assigned Interventions

Active Comparator: 1

Botulinum toxin type A

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 Name: BOTOX®

Placebo Comparator: 2

Placebo

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.

Eligibility

Ages Eligible for Study:	18 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00549783

Locations

Canada, Alberta

Edmonton, Alberta, Canada
Germany

Beelitz, 14547 Beelitz, Germany
Sweden

Uppsala, 75185 Uppsala, Sweden
United Kingdom

Burslem, Stoke-on-Trent, United Kingdom

Sponsors and Collaborators

Allergan

Investigators

Study Director:

Medical Director

Allergan

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided by Allergan

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Borg J, Ward AB, Wissel J, Kulkarni J, Sakel M, Ertzgaard P, Åkerlund 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.

Responsible Party:	Therapeutic Area Head, Allergan, Inc.
ClinicalTrials.gov Identifier:	NCT00549783 History of Changes
Other Study ID Numbers:	AGN/HO/SPA/001-191622
Study First Received:	October 24, 2007
Last Updated:	November 3, 2010
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices; Sweden: Medical Products Agency; United Kingdom: Medicines and Healthcare Products Regulatory Agency; Canada: Health Canada

Additional relevant MeSH terms:

Muscle Spasticity
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Botulinum Toxins, Type A

Botulinum Toxins
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012