Safety Study of Botulinum Toxin Type A in Post-Upper Limb Stroke Patients With Reduced Lung Function

Allergan

Status and phase: Completed; Phase 2

Conditions: Motor Neuron Disease; Stroke; Muscle Spasticity

Treatments: Biological: botulinum toxin Type A; Drug: saline

Study type: Interventional

Funder types: Industry

Identifiers

NCT00076687

191622-057

Details and patient eligibility

About

The purpose of this study is to evaluate the safety of injections of botulinum toxin Type A in patients with reduced lung function and focal upper limb poststroke spasticity

Enrollment: 155 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Abnormal pulmonary function test results;
• focal, upper limb spasticity, upper motor neuron syndrome

Exclusion criteria

• Previous exposure to botulinum toxin of any serotype

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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155 participants in 3 patient groups, including a placebo group

1

Experimental group

Treatment:

Biological: botulinum toxin Type A

Biological: botulinum toxin Type A

2

Experimental group

Treatment:

Biological: botulinum toxin Type A

Biological: botulinum toxin Type A

3

Placebo Comparator group

Treatment:

Drug: saline