Safety of New Formulation of Glatiramer Acetate

NCT ID: NCT00947752

Last Updated: 2017-03-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 147 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-07-31
• Study Completion Date: 2009-11-30

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.

Conditions

Relapsing Remitting Multiple Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

F1 Glatiramer acetate 20mg/1.0ml

Group Type: ACTIVE_COMPARATOR

Glatiramer Acetate

Intervention Type: DRUG

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.

F2 Glatiramer acetate 20mg/0.5ml

Group Type: EXPERIMENTAL

Experimental Glatiramer Acetate

Intervention Type: DRUG

GA 20 mg/0.5 mL

Interventions

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.

Intervention Type: DRUG

Experimental Glatiramer Acetate

GA 20 mg/0.5 mL

Intervention Type: DRUG

Other Intervention Names

F1; F2

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Teva Branded Pharmaceutical Products R&D, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tom Smith, MD

Role: STUDY_DIRECTOR

Teva Neuroscience, Inc.

Related Links

http://en.wikipedia.org/wiki/Visual_analogue_scale

Visual Analog Scale definition

Other Identifiers

PM033

Identifier Type: -

Identifier Source: org_study_id