- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02145689
Long-Term Study of OnabotulinumtoxinA Treatment in Adult Patients With Upper Limb Spasticity
August 12, 2014 updated by: Allergan
This is a long-term safety and efficacy study of onabotulinumtoxinA in poststroke patients with upper limb spasticity.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: onabotulinumtoxinA Dose 1
Up to 4 treatments of onabotulinumtoxinA Dose 1 injected into muscles of the study limb on fulfillment of the retreatment criteria.
|
Up to 4 treatments of onabotulinumtoxinA injected into muscles of the study limb on fulfillment of the retreatment criteria.
Other Names:
|
Experimental: onabotulinumtoxinA Dose 2
Up to 4 treatments of onabotulinumtoxinA Dose 2 injected into muscles of the study limb on fulfillment of the retreatment criteria.
|
Up to 4 treatments of onabotulinumtoxinA injected into muscles of the study limb on fulfillment of the retreatment criteria.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change from Baseline in the Modified Ashworth Scale-Bohannon (MAS-B) Score of Treated Muscle Groups Using a 6-Point Scale
Time Frame: Baseline, Up to 60 Weeks
|
Baseline, Up to 60 Weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Clinical Global Impression (CGI) of Overall Change by Physician Compared to Baseline Using a 9-Point Scale
Time Frame: Baseline, Up to 60 Weeks
|
Baseline, Up to 60 Weeks
|
Change from Baseline in Pain on an 11-Point Scale
Time Frame: Baseline, Up to 60 Weeks
|
Baseline, Up to 60 Weeks
|
Change from Baseline in the 19-Item Spasticity Impact Assessment-Upper Limb (SIA-UL) Score
Time Frame: Baseline, Up to 60 Weeks
|
Baseline, Up to 60 Weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2014
Primary Completion (Anticipated)
May 1, 2017
Study Completion (Anticipated)
May 1, 2017
Study Registration Dates
First Submitted
May 21, 2014
First Submitted That Met QC Criteria
May 21, 2014
First Posted (Estimate)
May 23, 2014
Study Record Updates
Last Update Posted (Estimate)
August 13, 2014
Last Update Submitted That Met QC Criteria
August 12, 2014
Last Verified
August 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nervous System Diseases
- Neurologic Manifestations
- Musculoskeletal Diseases
- Muscular Diseases
- Neuromuscular Manifestations
- Muscle Hypertonia
- Muscle Spasticity
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Cholinergic Agents
- Membrane Transport Modulators
- Acetylcholine Release Inhibitors
- Neuromuscular Agents
- Botulinum Toxins
- Botulinum Toxins, Type A
- abobotulinumtoxinA
Other Study ID Numbers
- 191622-129
- 2013-002327-42 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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