Safety Study of Botulinum Toxin Type A for the Treatment of Focal Upper Limb Poststroke Spasticity

The purpose of this study is to evaluate the safety of repeated doses of Botulinum Toxin Type A for the treatment of focal upper limb poststroke spasticity

Completed

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Muscle Hypertonia Muscle Spasticity Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Vancouver, British Columbia, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Medically stable poststroke patients with spastic muscles in the upper limb

Exclusion criteria

Stroke within 6 months of study enrollment
Previous therapy with Botulinum Toxin Type A for treatment of any condition prior to 4 months of enrollment, for treatment of any condition prior to 01 January 1998

Treatment and study plan

Botulinum toxin type A

Biological

Each patient received from 1 to 5 treatments, with a minimum of 12 weeks between treatments. For each treatment, a total dose of 200 U to 400 U botulinum toxin Type A was injected into the wrist and finger flexor muscles of the affected upper limb, not to exceed 6 U/kg

Other names: BOTOX®

Primary outcomes

Adverse events

Time frame: Week 54

Secondary outcomes

Spasticity as measured by the Ashworth scale

Time frame: Week 54

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Important dates

Study start: 2003
Primary completion: 2004
Study completion: 2004
First posted: Apr 3, 2008
Registry last updated: May 28, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed