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

Primary Purpose

Muscle Spasticity, Stroke

Status
Withdrawn
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
onabotulinumtoxinA
Sponsored by
Allergan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Muscle Spasticity

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    onabotulinumtoxinA Dose 1

    onabotulinumtoxinA Dose 2

    Arm Description

    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 Dose 2 injected into muscles of the study limb on fulfillment of the retreatment criteria.

    Outcomes

    Primary Outcome Measures

    Change from Baseline in the Modified Ashworth Scale-Bohannon (MAS-B) Score of Treated Muscle Groups Using a 6-Point Scale

    Secondary Outcome Measures

    Clinical Global Impression (CGI) of Overall Change by Physician Compared to Baseline Using a 9-Point Scale
    Change from Baseline in Pain on an 11-Point Scale
    Change from Baseline in the 19-Item Spasticity Impact Assessment-Upper Limb (SIA-UL) Score

    Full Information

    First Posted
    May 21, 2014
    Last Updated
    August 12, 2014
    Sponsor
    Allergan
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02145689
    Brief Title
    Long-Term Study of OnabotulinumtoxinA Treatment in Adult Patients With Upper Limb Spasticity
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2014
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    The study was withdrawn prior to enrollment due to corporate decision.
    Study Start Date
    August 2014 (undefined)
    Primary Completion Date
    May 2017 (Anticipated)
    Study Completion Date
    May 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Allergan

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Muscle Spasticity, Stroke

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    onabotulinumtoxinA Dose 1
    Arm Type
    Experimental
    Arm Description
    Up to 4 treatments of onabotulinumtoxinA Dose 1 injected into muscles of the study limb on fulfillment of the retreatment criteria.
    Arm Title
    onabotulinumtoxinA Dose 2
    Arm Type
    Experimental
    Arm Description
    Up to 4 treatments of onabotulinumtoxinA Dose 2 injected into muscles of the study limb on fulfillment of the retreatment criteria.
    Intervention Type
    Biological
    Intervention Name(s)
    onabotulinumtoxinA
    Other Intervention Name(s)
    BOTOX®, botulinum toxin type A
    Intervention Description
    Up to 4 treatments of onabotulinumtoxinA injected into muscles of the study limb on fulfillment of the retreatment criteria.
    Primary Outcome Measure Information:
    Title
    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 Outcome Measure Information:
    Title
    Clinical Global Impression (CGI) of Overall Change by Physician Compared to Baseline Using a 9-Point Scale
    Time Frame
    Baseline, Up to 60 Weeks
    Title
    Change from Baseline in Pain on an 11-Point Scale
    Time Frame
    Baseline, Up to 60 Weeks
    Title
    Change from Baseline in the 19-Item Spasticity Impact Assessment-Upper Limb (SIA-UL) Score
    Time Frame
    Baseline, Up to 60 Weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Director
    Organizational Affiliation
    Allergan
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

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

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