Safety of New Formulation of Glatiramer Acetate (Song)

This study has been completed.
Sponsor:
Information provided by:
Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier:
NCT00947752
First received: July 25, 2009
Last updated: May 10, 2011
Last verified: May 2011
  Purpose

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 Intervention Phase
Relapsing Remitting Multiple Sclerosis
Drug: Glatiramer Acetate
Drug: Experimental Glatiramer Acetate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:
  • Subject-reported Pain Associated Immediately After Each Injection [ Time Frame: 5 weeks of injections ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 5 weeks of injections ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 147
Study Start Date: July 2009
Study Completion Date: November 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00947752

Sponsors and Collaborators
Teva Pharmaceutical Industries
Investigators
Study Director: Tom Smith, MD Teva Neuroscience, Inc.
  More Information

Additional Information:
No publications provided

Responsible Party: Tom Smith, VP Medical Affairs, Teva Neuroscience, Inc.
ClinicalTrials.gov Identifier: NCT00947752     History of Changes
Other Study ID Numbers: PM033
Study First Received: July 25, 2009
Results First Received: September 28, 2010
Last Updated: May 10, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Teva Pharmaceutical Industries:
Multiple Sclerosis
Relapsing Remitting Multiple Sclerosis (RRMS)
Glatiramer Acetate (GA)

Additional relevant MeSH terms:
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Sclerosis
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Demyelinating Autoimmune Diseases, CNS
Demyelinating Diseases
Immune System Diseases
Nervous System Diseases
Pathologic Processes
Copolymer 1
Adjuvants, Immunologic
Immunologic Factors
Immunosuppressive Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 30, 2014