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Evaluation of Two Glatiramer Acetate (GA) Formulations in Relapsing-Remitting Multiple Sclerosis (RRMS) Patients

NCT01167426 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 148

Last updated 2013-10-17

Study results available
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Summary

This is an open-label, multicenter study conducted at approximately 20 sites. Each patient will inject GA daily for 6 weeks utilizing an autoject 2 device to determine overall injection satisfaction.

Conditions

Interventions

DRUG

Glatiramer Acetate 20 mg/0.5 mL

20 mg/1.0 mL formulation of glatiramer acetate utilizing the autoject 2 for glass syringe.

DRUG

Glatiramer acetate 20 mg/0.5 mL

20 mg/0.5 mL formulation of glatiramer acetate utilizing the autoject 2 20 mg/0.5 mL device.

Sponsors & Collaborators

  • Teva Neuroscience, Inc.

    lead INDUSTRY

Principal Investigators

  • Tom Smith, MD · Teva Neuroscience, Inc.

Study Design

Allocation
NON_RANDOMIZED
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2010-11-30
Completion
2010-12-31

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01167426 on ClinicalTrials.gov