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

Allergan155 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

155

Conditions

Stroke Muscle Spasticity Motor Neuron Disease

Interventions

botulinum toxin Type ABIOLOGICAL

botulinum toxin Type A 240 U injection on Day 1, Week 12, Week 18

botulinum toxin Type ABIOLOGICAL

botulinum toxin Type A 360 U injection at Day 1, Week 12, Week 18

salineDRUG

Saline injection at Day 1, Week 12, Week 18

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (4)

Unnamed facility

Miami, Florida, United States

Unnamed facility

Prague, Czechia

Unnamed facility

Szeged, Hungary

Unnamed facility

Warsaw, Poland

Outcomes

Primary Outcomes

Change From Baseline in Forced Vital Capacity (FVC)

Change from baseline in observed FVC. FVC is the maximum amount of air exhaled from the lungs after taking the deepest breath possible. Patients perform three to eight exhalations into a spirometer with the highest value recorded at Baseline and Week 6.

Time frame: Baseline, Week 6

Change From Baseline in Forced Expiratory Volume (FEV1)

Change from baseline in observed FEV1 at one second. FEV1 is the maximum amount of air exhaled in one second. Patients perform three to eight exhalations into a spirometer with the highest value recorded at Baseline and Week 6.

Time frame: Baseline, Week 6

Secondary Outcomes

Change From Baseline in FEV1/FVC Ratio

Change from baseline in FEV1/FVC ratio. This ratio is calculated by dividing the FEV1 value by the FVC value. This represents that portion (or ratio) of FVC exhaled in one second.

Time frame: Baseline, Week 6

Change From Baseline in Ashworth Scale

Change from Baseline in worst upper limb scores using the Ashworth Scale at Week 6 from Baseline. Upper limb includes finger, wrist, thumb, and elbow. Worst score was the highest value measured from the finger, wrist, thumb, or elbow at Baseline and Week 6 based on treated areas. The Ashworth Scale assesses the degree of muscle tone. It is a 5-point scale where 0 equals no increase in muscle tone and 4 equals very severe muscle rigidity. A low score indicates little or no stiffness. A high score indicates severe stiffness. A negative change from baseline score indicates improvement.

Time frame: Baseline, Week 6

Data from ClinicalTrials.gov

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