Zenapax to Treat Multiple Sclerosis

Completed · Phase 2

Conditions studied: Multiple Sclerosis

In brief

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. ...

Key facts

Study ID

NCT00001934

Run by

National Institute of Neurological Disorders and Stroke (NINDS)

People needed

22

Starts

1999-09-01

Expected to finish

2008-09-01

Last updated by the study team

2011-08-05

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Diagnosis of primary progressive MS, defined as gradual progression of disability from the onset without relapses.
• Abnormal screening/pre-treatment blood tests exceeding any of the limits defined below:
• Alanine transaminase (ALT) or aspartate transaminase (AST) greater than two times the upper limit of normal;
• Total white blood cell count less than 3,000/mm(3);
• CD4+ count less than 320/mm(3);
• Platelet count less than 80,000/mm(3);
• Creatinine greater than 2.0 mg/dL.
• Concurrent, clinically significant (as determined by the investigator) cardiac, immunologic, pulmonary, neurologic, renal, and/or other major disease.
• Any contraindication to monoclonal antibody therapies.
• Patients who are HIV+ since the effects of anti-Tac are not defined in these patients.
• If prior treatment was received, the subject must have been off treatment for the required period prior to enrollment.
• Prior treatment with any other investigational drug or procedure for MS.
• History of alcohol or drug abuse within the 5 years prior to enrollment.
• Male and female subjects not practicing adequate contraception.
• Female subjects who are not post-menopausal or surgically sterile must be using an acceptable method of contraception. Acceptability of various methods of contraception will be at the discretion of the investigator. Written documentation that the subject is post-menopausal or surgically sterile must be available prior to study start.
• Unwillingness or inability to comply with the requirements of this protocol including the presence of any condition (physical, mental, or social) that is likely to affect the subject's returning for follow-up visits on schedule.
• Previous participation in this study.
• Breastfeeding patients.

Where it is running

• National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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