Find A Research Study

Once you have agreed to enter the study, you will be randomly assigned (by chance) to receive BG00012, placebo, or GA. This is done so that each group has a similar mix of subjects. In this study, you will have a 2 in 4 chance of receiving BG00012, a 1 in 4 chance of receiving GA, and a 1 in 4 chance of receiving placebo. The placebo looks just like BG00012, but contains no medicine. In this study, there will be 4 groups. • Group 1: 308 subjects will receive BG00012, 480 mg daily • Group 2: 308 subjects will receive BG00012, 720 mg daily • Group 3: 308 subjects will receive placebo • Group 4: 308 subjects will receive GA, 20 mg subcutaneous (SC – under the skin) injection, daily Because this is a blinded study, you, the study doctor, and the study staff will not know whether you are receiving BG00012 or placebo. If there is a medical emergency, your study doctor will be able to find out what study drug you are receiving. If you are assigned to Group 4, you and some of the study staff will know you are receiving GA. During the study, subjects in Group 1, 2, and 3 receiving BG00012 or placebo will begin the study by taking 1 capsule orally 3 times daily for 1 week. On Day 8, subjects will increase daily dosing to 2 capsules orally 3 times daily. BG00012 or placebo will be taken by mouth and should always be taken with food. After a single dose (2 capsules) of BG00012, the effects will remain in your body for approximately 8 hours. Subjects in Group 4 will self-inject 20 mg GA SC once daily.

People ages 18-55 who give consent to participate in this trial and who have a confirmed diagnosis of relapsing remitting multiple sclerosis with at least 1 relapse within 12 months are eligible to participate in this trial.
People who are unable to complete the testing required for the study, have abnormal laboratory values at screening, or a history of GA use will be excluded.

You can expect at least 27 clinic visits during the 2-year study, although more visits may be required if your study doctor decides they are needed for medical reasons. If you decide to be in this study, you agree to come to the clinic for the following visits:

• 1 Screening Visit (to see if you are eligible for the study)
• 26 scheduled visits (to follow your progress during the study); these visits will be done every 4 weeks
• Unscheduled Relapse Visits (only needed if you have a suspected relapse during the study and the study doctor decides a visit is needed)

• Unscheduled monitoring visits (if your laboratory test results are abnormal)
• Premature Study Withdrawal Visit (only needed if you leave the study early).

During the study, some or all of the following tests will be repeated to monitor your progress, check the safety of the study drug, and for research purposes:

• medical history
• neurological evaluations including dexterity, walking, and visual tests
• subject questionnaires
• recording adverse events (which are undesirable or unwanted effects, side effects)
• recording medications (past and present)
• a physical exam and vital signs (heart rate, blood pressure, and temperature)
• electrocardiogram (ECG) (which is a measure of your heart function)
• a blood and urine pregnancy test for women able to become pregnant
• routine blood and urine tests. (An analysis of some of the blood samples will also be done to gather information about how BG00012 works in the body.) This includes blood tests for Hepatitis B and C.

If you are eligible and decide to participate in the study, you will need to do the following things:

• report to the study clinic for all scheduled visits and other visits as requested by the study staff
• follow instructions on taking and returning study drug
• report any undesirable or unwanted effects (adverse events), and
• report taking any additional medications (including herbal or alternative remedies).

Study Summary:

Detailed Study Description:

Study Design: Blinded
Phase of Study: Phase III
Study Type: Interventional
Condition or Study Focus: Relapsing Remitting Multiple Sclerosis
Intervention Type: Drug
Intervention Name: BG00012
Gender: Male and Female
Age group: Interventional
Sponsor: Biogen Idec