Safety of New Formulation of Glatiramer Acetate (Song)
This study has been completed.
Sponsor:
Teva Pharmaceutical Industries
Information provided by:
Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier:
NCT00947752
First received: July 25, 2009
Last updated: May 10, 2011
Last verified: May 2011
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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:
Genetics Home Reference related topics:
multiple sclerosis
MedlinePlus related topics:
Multiple Sclerosis
U.S. FDA Resources
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 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 Sclerosis Multiple Sclerosis, Relapsing-Remitting Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System Nervous System Diseases Demyelinating Diseases Autoimmune Diseases |
Immune System Diseases Pathologic Processes Copolymer 1 Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Immunosuppressive Agents |
ClinicalTrials.gov processed this record on May 23, 2013