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Safety of New Formulation of Glatiramer Acetate (Song)

Primary Purpose

Relapsing Remitting Multiple Sclerosis

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Glatiramer Acetate
Experimental Glatiramer Acetate
Sponsored by
Teva Branded Pharmaceutical Products R&D, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Relapsing Remitting Multiple Sclerosis focused on measuring Multiple Sclerosis, Relapsing Remitting Multiple Sclerosis (RRMS), Glatiramer Acetate (GA)

Eligibility Criteria

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

Inclusion Criteria:

  • Subjects ≥ 18 years of age with a diagnosis of RRMS
  • Currently injecting GA 20mg/1.0mL per day subcutaneously (SC) for a minimum of 90 days utilizing the autoject®2 for glass syringe or by a manual injection technique
  • Willing to switch from autoject®2 for glass syringe to manual injection technique or continue with a manual injection technique during the course of the study
  • Willing and able to be trained on a seven site injection rotation. Subject must be willing to comply with a minimum five injection site rotation plan during the study
  • Willing and able to complete all procedures and evaluations related to the study
  • Willing to continue to follow usual injection site preparation and routine adjunctive LISR management techniques
  • Willing and able to provide written informed consent

Exclusion Criteria:

  • Currently using or treated with another immunomodulating therapy (IMT) in conjunction with GA in the 30 days prior to screening for this study
  • Currently using intermittent or pulse courses of corticosteroids by any route of administration in the 30 days prior to screening for this study. (Corticosteroids are prohibited for the duration of the study.)
  • Currently using an investigational drug or using treatment with any other investigational agent in the 30 days prior to screening for this study
  • Presence or history of skin necrosis
  • Known extensive dermatological condition that could be a confounding factor
  • Pregnant or planning pregnancy or breastfeeding
  • Any physical condition that impairs ability to be injected at the minimum of five sites rotation
  • Not able or willing to complete a daily diary
  • Use of any other parenteral medications (e.g., intramuscular, SC, intravenous, etc.) either currently or in the past 30 days prior to screening for this study
  • Any other medical or psychiatric conditions that would make the subject unsuitable for this research, as determined by the Investigator
  • Previous participation in this study

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    F1 Glatiramer acetate 20mg/1.0ml

    F2 Glatiramer acetate 20mg/0.5ml

    Arm Description

    Outcomes

    Primary Outcome Measures

    Subject-reported Pain Associated Immediately After Each Injection
    A visual analog scale (VAS) was used for subjective characteristics that cannot be directly measured. Respondents specified their level of agreement to a statement by indicating a position along a continuous line between two end-points. The VAS scale used 0 mm to represent "no pain" and up to 100 mm to represent "worst possible pain;" subjects drew a continuous line to represent their level of pain.

    Secondary Outcome Measures

    Degree of Pain Within 5 Mins After Injection
    A visual analog scale (VAS) was used for subjective characteristics that cannot be directly measured. Respondents specified their level of agreement to a statement by indicating a position along a continuous line between two end-points. The VAS scale used 0 mm to represent "no pain" and up to 100 mm to represent "worst possible pain;" subjects drew a continuous line to represent their level of pain.

    Full Information

    First Posted
    July 25, 2009
    Last Updated
    February 2, 2017
    Sponsor
    Teva Branded Pharmaceutical Products R&D, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00947752
    Brief Title
    Safety of New Formulation of Glatiramer Acetate
    Acronym
    Song
    Official Title
    An Open-Label, Multicenter, Randomized Study Evaluating the Tolerability and Safety of Two Formulations of Glatiramer Acetate (GA) for Subcutaneous Injection
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2009 (undefined)
    Primary Completion Date
    September 2009 (Actual)
    Study Completion Date
    November 2009 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Teva Branded Pharmaceutical Products R&D, Inc.

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to compare pain associated with injections and injection-site reactions of the approved formulation of Glatiramer Acetate (GA) versus investigational formulation of GA. In addition, the investigators will evaluate the side effects of the two formulations of GA.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Relapsing Remitting Multiple Sclerosis
    Keywords
    Multiple Sclerosis, Relapsing Remitting Multiple Sclerosis (RRMS), Glatiramer Acetate (GA)

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Crossover Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    147 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    F1 Glatiramer acetate 20mg/1.0ml
    Arm Type
    Active Comparator
    Arm Title
    F2 Glatiramer acetate 20mg/0.5ml
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    Glatiramer Acetate
    Other Intervention Name(s)
    F1
    Intervention Description
    Subjects received both doses once daily in a crossover fashion, for a total treatment duration of five weeks, including a one-week run-in period. Subject-reported injection pain was recorded in a daily diary.
    Intervention Type
    Drug
    Intervention Name(s)
    Experimental Glatiramer Acetate
    Other Intervention Name(s)
    F2
    Intervention Description
    GA 20 mg/0.5 mL
    Primary Outcome Measure Information:
    Title
    Subject-reported Pain Associated Immediately After Each Injection
    Description
    A visual analog scale (VAS) was used for subjective characteristics that cannot be directly measured. Respondents specified their level of agreement to a statement by indicating a position along a continuous line between two end-points. The VAS scale used 0 mm to represent "no pain" and up to 100 mm to represent "worst possible pain;" subjects drew a continuous line to represent their level of pain.
    Time Frame
    5 weeks of injections
    Secondary Outcome Measure Information:
    Title
    Degree of Pain Within 5 Mins After Injection
    Description
    A visual analog scale (VAS) was used for subjective characteristics that cannot be directly measured. Respondents specified their level of agreement to a statement by indicating a position along a continuous line between two end-points. The VAS scale used 0 mm to represent "no pain" and up to 100 mm to represent "worst possible pain;" subjects drew a continuous line to represent their level of pain.
    Time Frame
    5 weeks of injections

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Subjects ≥ 18 years of age with a diagnosis of RRMS Currently injecting GA 20mg/1.0mL per day subcutaneously (SC) for a minimum of 90 days utilizing the autoject®2 for glass syringe or by a manual injection technique Willing to switch from autoject®2 for glass syringe to manual injection technique or continue with a manual injection technique during the course of the study Willing and able to be trained on a seven site injection rotation. Subject must be willing to comply with a minimum five injection site rotation plan during the study Willing and able to complete all procedures and evaluations related to the study Willing to continue to follow usual injection site preparation and routine adjunctive LISR management techniques Willing and able to provide written informed consent Exclusion Criteria: Currently using or treated with another immunomodulating therapy (IMT) in conjunction with GA in the 30 days prior to screening for this study Currently using intermittent or pulse courses of corticosteroids by any route of administration in the 30 days prior to screening for this study. (Corticosteroids are prohibited for the duration of the study.) Currently using an investigational drug or using treatment with any other investigational agent in the 30 days prior to screening for this study Presence or history of skin necrosis Known extensive dermatological condition that could be a confounding factor Pregnant or planning pregnancy or breastfeeding Any physical condition that impairs ability to be injected at the minimum of five sites rotation Not able or willing to complete a daily diary Use of any other parenteral medications (e.g., intramuscular, SC, intravenous, etc.) either currently or in the past 30 days prior to screening for this study Any other medical or psychiatric conditions that would make the subject unsuitable for this research, as determined by the Investigator Previous participation in this study
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Tom Smith, MD
    Organizational Affiliation
    Teva Neuroscience, Inc.
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Links:
    URL
    http://en.wikipedia.org/wiki/Visual_analogue_scale
    Description
    Visual Analog Scale definition

    Learn more about this trial

    Safety of New Formulation of Glatiramer Acetate

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