Clinical trial NCT00947752: Safety of New Formulation of Glatiramer Acetate
Official title: An Open-Label, Multicenter, Randomized Study Evaluating the Tolerability and Safety of Two Formulations of Glatiramer Acetate (GA) for Subcutaneous Injection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Relapsing Remitting Multiple Sclerosis
Keywords: Multiple Sclerosis
Relapsing Remitting Multiple Sclerosis (RRMS)
Glatiramer Acetate (GA)
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2009-07-28
Enrollment: 147
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Subject-reported Pain Associated Immediately After Each Injection
timeFrame: 5 weeks of injections
Secondary outcomes:
measure: Degree of Pain Within 5 Mins After Injection
timeFrame: 5 weeks of injections
Other outcomes:
Locations:
Study officials:
affiliation: Teva Neuroscience, Inc.
name: Tom Smith, MD
role: STUDY_DIRECTOR
References: