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Clinical Trials/NCT02145689
NCT02145689WithdrawnPhase 3

Long-Term Study of OnabotulinumtoxinA Treatment in Adult Patients With Upper Limb Spasticity

Allergan0 sitesStarted: August 1, 2014Last updated:
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Conditions

Trial Snapshot

Phase
Phase 3
Status
Withdrawn
Sponsor
Allergan
Primary Endpoint
Change from Baseline in the Modified Ashworth Scale-Bohannon (MAS-B) Score of Treated Muscle Groups Using a 6-Point Scale
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

This is a long-term safety and efficacy study of onabotulinumtoxinA in poststroke patients with upper limb spasticity.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Investigator)

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Change from Baseline in the 19-Item Spasticity Impact Assessment-Upper Limb (SIA-UL) Score(Baseline, Up to 60 Weeks)
  • 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)

Investigators

Sponsor
Allergan
Sponsor Class
Industry
Responsible Party
Sponsor

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