Research Study for Children age 10 – 17 with Multiple Sclerosis

IRB/UVA Tracking #
20566
Principal Investigator
Brenton J. Nicholas, N
Contact First Name

Margaret

Contact Last Name

Keller

Contact Email
Contact Phone
Official Trial Title
Open-Label, Randomized, Multicenter, Multiple-Dose, Active-Controlled, Parallel-Group, Efficacy and Safety Study of BG00012 in Children From 10 to Less Than 19 Years of Age With Relapsing-Remitting Multiple Sclerosis, With Optional Open-Label Extension
Study Description

The Department of Neurology seeks children ages 10 to less than 18 years with multiple sclerosis for a research study. The purpose of the study is see if an experimental drug (BG00012) is safe and effective in children, teenagers and young adults for the treatment of their multiple sclerosis.

You may be eligible for this study if: you have had a relapse in the past year, or 2 relapses in the past 2 years.

Study involves taking an experimental medication (randomized to either BG00012 by mouth twice a day, or Avonex by intramuscular injection weekly), blood draws, MRIs of the brain, cognitive testing, questionnaire completion, x-ray of your hand/wrist. You will have study visits for screening, on the day you start study treatment and at 10 other visits over about 2 years. Visits will last between 1 and 4 hours. There is the option of a long term extension study for eligible subjects that provides BG00012 for up to almost 5 additional years.

Study-related examinations, testing and study medication are provided free of charge.

Compensation

You will be reimbursed up to $200 per visit for your mileage travel expenses, based on the distance between your home and the clinic as calculated with Google maps.