Safety of New Formulation of Glatiramer Acetate

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Relapsing Remitting Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Multiple Sclerosis Multiple Sclerosis, Relapsing-Remitting Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Glatiramer Acetate

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.

Other names: F1

Experimental Glatiramer Acetate

Drug

GA 20 mg/0.5 mL

Other names: F2

Primary outcomes

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 outcomes

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.

Sponsors and collaborators

Lead sponsor

Teva Branded Pharmaceutical Products R&D, Inc.

Industry

Registry information

Official study title

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

Acronym: Song

Important dates

Study start: 2009
Primary completion: 2009
Study completion: 2009
First posted: Jul 28, 2009
Registry last updated: Mar 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed