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Safety of New Formulation of Glatiramer Acetate (Song)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00947752
Recruitment Status : Completed
First Posted : July 28, 2009
Results First Posted : June 9, 2011
Last Update Posted : March 14, 2017
Sponsor:
Information provided by (Responsible Party):
Teva Branded Pharmaceutical Products R&D, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Relapsing Remitting Multiple Sclerosis Drug: Glatiramer Acetate Drug: Experimental Glatiramer Acetate Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 147 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Multicenter, Randomized Study Evaluating the Tolerability and Safety of Two Formulations of Glatiramer Acetate (GA) for Subcutaneous Injection
Study Start Date : July 2009
Actual Primary Completion Date : September 2009
Actual Study Completion Date : November 2009

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: F1 Glatiramer acetate 20mg/1.0ml Drug: Glatiramer Acetate
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.
Other Name: F1
Experimental: F2 Glatiramer acetate 20mg/0.5ml Drug: Experimental Glatiramer Acetate
GA 20 mg/0.5 mL
Other Name: F2


Outcome Measures
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Primary Outcome Measures :
  1. Subject-reported Pain Associated Immediately After Each Injection [ Time Frame: 5 weeks of injections ]
    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 :
  1. Degree of Pain Within 5 Mins After Injection [ Time Frame: 5 weeks of injections ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00947752


Sponsors and Collaborators
Teva Branded Pharmaceutical Products R&D, Inc.
Investigators
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Study Director: Tom Smith, MD Teva Neuroscience, Inc.
More Information
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Additional Information:

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Responsible Party: Teva Branded Pharmaceutical Products R&D, Inc.
ClinicalTrials.gov Identifier: NCT00947752    
Other Study ID Numbers: PM033
First Posted: July 28, 2009    Key Record Dates
Results First Posted: June 9, 2011
Last Update Posted: March 14, 2017
Last Verified: February 2017
Keywords provided by Teva Branded Pharmaceutical Products R&D, Inc.:
Multiple Sclerosis
Relapsing Remitting Multiple Sclerosis (RRMS)
Glatiramer Acetate (GA)
Additional relevant MeSH terms:
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Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
 Immune System Diseases
Glatiramer Acetate
(T,G)-A-L
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Immunosuppressive Agents
Antirheumatic Agents