Study Stopped
The study was withdrawn prior to enrollment due to corporate decision.
Long-Term Study of OnabotulinumtoxinA Treatment in Adult Patients With Upper Limb Spasticity
2 other identifiers
interventional
N/A
0 countries
N/A
Brief Summary
This is a long-term safety and efficacy study of onabotulinumtoxinA in poststroke patients with upper limb spasticity.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Aug 2014
Typical duration for phase_3
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
First Submitted
Initial submission to the registry
May 21, 2014
CompletedFirst Posted
Study publicly available on registry
May 23, 2014
CompletedStudy Start
First participant enrolled
August 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2017
CompletedAugust 13, 2014
August 1, 2014
2.8 years
May 21, 2014
August 12, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Change from Baseline in the Modified Ashworth Scale-Bohannon (MAS-B) Score of Treated Muscle Groups Using a 6-Point Scale
Baseline, Up to 60 Weeks
Secondary Outcomes (3)
Clinical Global Impression (CGI) of Overall Change by Physician Compared to Baseline Using a 9-Point Scale
Baseline, Up to 60 Weeks
Change from Baseline in Pain on an 11-Point Scale
Baseline, Up to 60 Weeks
Change from Baseline in the 19-Item Spasticity Impact Assessment-Upper Limb (SIA-UL) Score
Baseline, Up to 60 Weeks
Study Arms (2)
onabotulinumtoxinA Dose 1
EXPERIMENTALUp to 4 treatments of onabotulinumtoxinA Dose 1 injected into muscles of the study limb on fulfillment of the retreatment criteria.
onabotulinumtoxinA Dose 2
EXPERIMENTALUp to 4 treatments of onabotulinumtoxinA Dose 2 injected into muscles of the study limb on fulfillment of the retreatment criteria.
Interventions
Up to 4 treatments of onabotulinumtoxinA injected into muscles of the study limb on fulfillment of the retreatment criteria.
Eligibility Criteria
You may qualify if:
- For patients entering from the 191622-127 study, successful completion of study 191622-127
- For patients entering directly into study 191622-129, upper limb spasticity in the elbow and shoulder due to stroke, with the most recent stroke at least 3 months ago
You may not qualify if:
- Spasticity in the non-study upper limb that requires treatment
- Presence of fixed contractures in of the study muscles in elbow or shoulder
- Profound atrophy of muscles to be injected
- Previous surgical intervention, nerve block, or muscle block for the treatment of spasticity in the study limb in the last 12 months
- Injection of corticosteroids or anesthetics, use of casting or dynamic splinting or constraint-induced movement therapy (CIMT) for the study limb within 3 months
- Ultrasound therapy, electrical stimulation, or acupuncture in the study limb within 1 month
- Condition other than stroke contributing to upper limb spasticity
- Diagnosis of myasthenia gravis, Eaton-Lambert syndrome, and/or amyotrophic lateral sclerosis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Allerganlead
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Allergan
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 21, 2014
First Posted
May 23, 2014
Study Start
August 1, 2014
Primary Completion
May 1, 2017
Study Completion
May 1, 2017
Last Updated
August 13, 2014
Record last verified: 2014-08