OMEGA-Oral Megadose Corticosteroid Therapy of Acute Exacerbations in Multiple Sclerosis

IRB Approved 10/01/03 through 9/30/2004

This study will compare the use of oral versus intravenous (into the vein) steroids in relapsing forms of Multiple Sclerosis (MS).  Every subject will receive one form of the active medication and one form of the inactive medication. Treatment will given for 5 days and subjects will be followed for 12 months. 

Female and male volunteers 18-50 years old with Relapsing Forms of Multiple Sclerosis who are presently experiencing an acute exacerbation (flare up) of MS within the past 7 days.   You may continue any current immunomodulating therapy to treat the MS (For example: interferons, glatiramer acetate, mitoxantrone). Cannot participate if you are pregnant at time of acute attack.  Evaluations and tests will be paid for by the study. Must meet eligibility criteria.

If interested, please contact the study coordinator Michele Weber at 212-241-4264 or at Michele.Weber@mssm.edu.

A Multi-Centered, Open Label Study to Evaluate Induction Treatment with Mitoxantrone (Novantrone®) Treatment and Glatiramer Acetate (Copaxone®) in Relapsing Forms of Multiple Sclerosis.

This research study will evaluate the safety and tolerability of 2 treatment groups. One group will start glatiramer acetate. The second group will receive mitoxantrone for three consecutive months followed by starting glatiramer acetate in patients with Relapsing Remitting Multiple Sclerosis (MS).  Both glatiramer acetate and mitoxantrone are approved medications by the Food and Drug Administration (FDA) for MS. However, shortening the time period between the mitoxantrone infusions from 3 months to one month is not FDA approved. Both you and the study doctor will know what medication you are receiving .

Female and male volunteers 18-55 years old with Relapsing Forms of Multiple Sclerosis who are not on current therapy. Cannot participate if you are pregnant or planning a pregnancy and must practice 2 forms of birth control. Medications, evaluations, and tests will be paid for by the study. Subjects will be reimbursed for parking expenses up to $20. The study will last for about 15 months. Must meet eligibility criteria.

Dr. Fred Lublin and Dr. Mark Tullman are the doctors involved with this project. If interested, please contact the study coordinator Michele Weber at 212-241-4264 or at Multiple.Sclerosis@mssm.edu.

5-year study of tolerability and safety monitoring for open label Novantrone® (mitoxantrone) infusions in Multiple Sclerosis Patients.

GCO# 01-0721 APPROVAL PERIOD: 12/01/03 through 11/30/04

This open label study will follow subjects who are eligible for standard treatment with Novantrone for 5 years. We are conducting this study to collect information about the side effects over a long period of time. Participants are responsible for all costs associated with the study. We are looking for female and male volunteers 18-65 years old with worsening Relapsing Remitting or Secondary Progressive Multiple Sclerosis who are not on any current immunomodulating therapy (For example: interferons, glatiramer acetate). Cannot participate if you are pregnant or planning a pregnancy and must practice effective birth control. Must meet eligibility criteria.

If interested, please contact the study coordinator Michele Weber at 212-241-4264 or at Multiple.Sclerosis@mssm.edu.