Safety of New Formulation of Glatiramer Acetate

Relapsing Remitting Multiple Sclerosis Clinical Trial

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Official title:

An Open-Label, Multicenter, Randomized Study Evaluating the Tolerability and Safety of Two Formulations of Glatiramer Acetate (GA) for Subcutaneous Injection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00947752
• Other study ID #: PM033
• Status: Completed
• Phase: Phase 3
• First received: July 25, 2009
• Last updated: May 10, 2011
• Start date: July 2009
• Est. completion date: November 2009

Study information

• Verified date: May 2011
• Source: Teva Pharmaceutical Industries
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 147
• Est. completion date: November 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Relapsing Remitting Multiple Sclerosis
• Sclerosis

Intervention

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.
• Experimental Glatiramer Acetate
GA 20 mg/0.5 mL

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Teva Pharmaceutical Industries

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	5 weeks of injections	Yes
Secondary	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.	5 weeks of injections	Yes

External Links

•   Visual Analog Scale definition