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BOTOX® Economic Spasticity Trial (BEST)

NCT ID: NCT00549783

Last Updated: 2012-08-22

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

274 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2010-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Muscle Spasticity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Botulinum Toxin Type A 900kD

Intervention Type BIOLOGICAL

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.

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type BIOLOGICAL

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.

Interventions

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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.

Intervention Type 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.

Intervention Type BIOLOGICAL

Other Intervention Names

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BOTOX®

Eligibility Criteria

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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.)
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Allergan

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Allergan

Locations

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Edmonton, Alberta, Canada

Site Status

Beelitz, , Germany

Site Status

Uppsala, , Sweden

Site Status

Burslem, Stoke-on-Trent, United Kingdom

Site Status

Countries

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Canada Germany Sweden United Kingdom

References

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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.

Reference Type DERIVED
PMID: 21174051 (View on PubMed)

Other Identifiers

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AGN/HO/SPA/001-191622

Identifier Type: -

Identifier Source: org_study_id