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

Completed

Phase 2 Results

Trial Description

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

Conditions

Interventions

  • Botulinum toxin (Dysport)Drug
    Intervention Desc: Antispasticity agent.
  • Saline Drug
    Other Names: Sodium Chloride
    Intervention Desc: Saline injection at Day 1, Week 12, Week 18
    ARM 1: Kind: Experimental
    Label: 3
  • Botulinum toxin type A Biological
    Other Names: BOTOX®
    Intervention Desc: botulinum toxin Type A 360 U injection at Day 1, Week 12, Week 18
    ARM 1: Kind: Experimental
    Label: 1
    ARM 2: Kind: Experimental
    Label: 2

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Safety Study
  • Intervention: Parallel Assignment

Patient Involvement

Patients will receive injections in the arm or hand 2 times over the course of 32 weeks with 9 office visits.

Outcomes

Type Measure Time Frame Safety Issue
Primary Change in pulmonary functions from baseline.
Secondary Measure of muscle spacsticity/tightness before and after injection.
Primary Change from Baseline in Forced Expiratory Volume (FEV1) Baseline, Week 6 Yes
Primary Change from Baseline in Forced Vital Capacity (FVC) Baseline, Week 6 Yes
Secondary Change from Baseline in Ashworth Scale Baseline, Week 6 No
Secondary Change from Baseline in FEV1/FVC Ratio Baseline, Week 6 No

Sponsors