This study will examine the safety and effectiveness of Zenapax (a laboratory-manufactured
antibody) in treating multiple sclerosis. Multiple sclerosis may be caused by an abnormal
immune response in which white blood cells called T lymphocytes attack the myelin sheath that
covers nerves and parts of the spinal cord. Zenapax binds to protein receptors on
lymphocytes, keeping them from interacting with interleukin-2, a substance necessary for
their growth.
Patients with multiple sclerosis who have had at least one relapse within 18 months of the
start of the study and in whom interferon-beta treatment has not been successful may be
considered for this study. There are two study phases: baseline and treatment. During the
baseline phase, patients will have three magnetic resonance imaging (MRI) scans over 2 months
to evaluate their disease activity. During treatment, patients will receive seven intravenous
(I.V.) infusions of Zenapax in the clinic. The first two infusions will be given 2 weeks
apart; the next five will be given once a month.
Patients will have MRI scans before each infusion. The MRIs will be done using the standard
procedure and again using a contrast agent, gadolinium, injected into a vein. Gadolinium
helps identify new multiple sclerosis lesions in the brain. Blood and urine samples will be
taken during each clinic visit. In addition, patients will have skin tests, similar to a
tuberculin test, to evaluate immune status, and will be asked to undergo two lumbar punctures
(spinal tap; these will be optional)-one before the treatment phase begins, and another when
treatment is completed. Lymphocytes will also be collected from patients before, during and
after treatment. The lymphocytes are obtained by a procedure called apheresis: about a pint
of whole blood is drawn through a needle in the arm, the lymphocytes are separated out and
removed by a machine, and the rest of the blood is returned through a needle in the other
arm. These studies will hopefully allow conclusions about the safety of Zenapax in MS, but
also address its effectiveness with respect to modifying the inflammatory activity in the
brain of MS patients and inhibit autoimmune T lymphocytes that are involved in the disease
process.
...
Phase:
Phase 2
Details
Lead Sponsor:
National Institute of Neurological Disorders and Stroke (NINDS)