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

Inclusion criteria

• The subject must have undergone a single clinical attack.
• The subject must have a unifocal clinical presentation.
• The subject should be enrolled within the period of 90 days after onset of a single unifocal clinical attack (index attack).
• There must be 2 or more cerebral lesions highly suspicious of multiple sclerosis (MS) on the screening Magnetic Resonance Imaging (MRI), measuring 6mm or more in diameter.
• Subjects must be between the ages of 18 and 45 years inclusive.
• Subjects must not have taken corticosteroids within the 30 days prior to the MRI at the baseline visit.
• Subjects may be male or female. Women of child-bearing potential must practice a medically acceptable method of birth control. Acceptable methods include oral contraceptive, contraceptive patch, long-acting injectable contraceptive, or double-barrier method (condom or intrauterine device with spermicide).
• The subjects must be willing and able to give written informed consent, prior to entering the study.

Exclusion criteria

• Multifocal clinical presentation.
• Diseases other than MS responsible for the clinical/MRI presentation. The following laboratory tests must be part of the subject's medical history for differential diagnosis of clinically isolated syndrome (CIS): erythrocyte sedimentation rate (ESR), antinuclear antibody (ANA), complement (C3, C4) and anticardiolipin IgG - IgM. In the event that the results of these tests are inconclusive, the following additional tests may be requested by the Eligibility Evaluation Committee: syphilis screening, vitamin B12 and folic acid. In the case of spinal cord CIS presentation, a spinal cord MRI is required for confirmation of diagnosis in the medical history of the subject.
• Use of experimental or investigational drugs, including IV immunoglobulin, and/or participation in an investigational drug study within 6 months prior to study entry.
• Use of interferon agents within 6 months prior to the screening visit.
• Chronic corticosteroid treatment (more than 30 consecutive days) in the 6 months prior to study entry.
• Pregnancy or breast feeding.
• Subjects who experience a relapse between the screening (month -1) and baseline (month 0) visits.
• Life-threatening or other clinically significant disease.
• A medical or psychiatric condition that affects the subject's ability to give informed consent, or to complete the study, or if the subject is considered by the treating neurologist/physician to be, for any other reason, an unsuitable candidate for this study.
• A known history of sensitivity to mannitol.
• A known history of sensitivity to gadolinium.
• Inability to successfully undergo MRI scanning.