Safety Study of Botulinum Toxin Type A in Post-Upper Limb Stroke Patients With Reduced Lung Function
1 other identifier
interventional
155
4 countries
4
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 stroke
Started Oct 2003
Longer than P75 for phase_2 stroke
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2003
CompletedFirst Submitted
Initial submission to the registry
January 29, 2004
CompletedFirst Posted
Study publicly available on registry
February 26, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2009
CompletedResults Posted
Study results publicly available
October 3, 2011
CompletedOctober 3, 2011
August 1, 2011
5.8 years
January 29, 2004
July 28, 2011
August 30, 2011
Conditions
Outcome Measures
Primary Outcomes (2)
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.
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.
Baseline, Week 6
Secondary Outcomes (2)
Change From Baseline in FEV1/FVC Ratio
Baseline, Week 6
Change From Baseline in Ashworth Scale
Baseline, Week 6
Study Arms (3)
1
EXPERIMENTAL2
EXPERIMENTAL3
PLACEBO COMPARATORInterventions
botulinum toxin Type A 240 U injection on Day 1, Week 12, Week 18
Eligibility Criteria
You may qualify if:
- Abnormal pulmonary function test results;
- focal, upper limb spasticity, upper motor neuron syndrome
You may not qualify if:
- Previous exposure to botulinum toxin of any serotype
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Allerganlead
Study Sites (4)
Unknown Facility
Miami, Florida, United States
Unknown Facility
Prague, Czechia
Unknown Facility
Szeged, Hungary
Unknown Facility
Warsaw, Poland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Therapeutic Area Head
- Organization
- Allergan, Inc.
Study Officials
- STUDY DIRECTOR
Medical Director
Allergan
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 29, 2004
First Posted
February 26, 2004
Study Start
October 1, 2003
Primary Completion
August 1, 2009
Study Completion
August 1, 2009
Last Updated
October 3, 2011
Results First Posted
October 3, 2011
Record last verified: 2011-08