NCT00666224View on ClinicalTrials.gov

Evaluate Early Glatiramer Acetate Treatment in Delaying Conversion to Clinically Definite Multiple Sclerosis of Subjects Presenting With Clinically Isolated Syndrome

PHASE3CompletedINTERVENTIONAL

Enrollment

481

Participants

Timeline

Start Date

January 31, 2004

Primary Completion Date

October 31, 2007

Study Completion Date

June 30, 2010

Conditions

Multiple Sclerosis

Interventions

DRUG

Glatiramer Acetate (DB)

Double blind period (DB): glatiramer acetate (GA) by subcutaneous injection, 20mg, once daily, for up to 36 months or until conversion to clinically definite multiple sclerosis (CDMS).

DRUG

Placebo

Double blind period (DB): subcutaneous injection of placebo, once daily, for up to 36 months or until conversion to CDMS

DRUG

Glatiramer Acetate (OL)

Open label period (OL): glatiramer acetate (GA), 20 mg, subcutaneous injection, once daily, given for up to an additional 24 months.

All Listed Sponsors

lead

Teva Branded Pharmaceutical Products R&D, Inc.

INDUSTRY

NCT00666224 - Evaluate Early Glatiramer Acetate Treatment in Delaying Conversion to Clinically Definite Multiple Sclerosis of Subjects Presenting With Clinically Isolated Syndrome | Biotech Hunter | Biotech Hunter