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Zenapax to Treat Multiple Sclerosis Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment by using a genuine medical doctor. We aren't mDs. Always confer with your doctor on Zenapax to Treat Multiple Sclerosis conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Zenapax to Treat Multiple Sclerosis Clinical research trials and Zenapax to Treat Multiple Sclerosis healthcare trials occur in a lot of of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new does drugs. The role of the studies / undertakings is to solve specific human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to find treatments for all kinds of conditions, including Zenapax to Treat Multiple Sclerosis. Zenapax to Treat Multiple Sclerosis Clinical Trials and other clinical trials allow for volunteers to access health treatment choices before they are available to the general public. Many times the test subjects get treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Zenapax to Treat Multiple Sclerosis clinical trial. Test subjects typically receive the most effective healthcare possible for their Zenapax to Treat Multiple Sclerosis condition. Risks are a reality, nonetheless, and could include extra or frequent dr. calls, health hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "Z" Clinical Trials Conditions > Zenapax to Treat Multiple Sclerosis  Zenapax to Treat Multiple Sclerosis
Zenapax to Treat Multiple Sclerosis
For Condition: Multiple Sclerosis
Status: Recruiting
Sponsor(s): National Institute of Neurological Disorders and Stroke (NINDS) ,
Synopsis: 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.
Details: Multiple sclerosis (MS) is an inflammatory and demyelinating disease of the central nervous system (CNS) that preferentially affects young adults. While its etiology is unknown, current concepts assume that CD4+ helper T cells with specificity for components of the myelin sheath initiate the pathogenetic process. The activation and expansion of such autoreactive T cells involves the secretion of autocrine growth factors, particularly interleukin-2 (IL-2), and the concomitant expression of its receptor, IL-2R, on the surface of T cells. Since only activated T lymphocytes can migrate through the blood brain barrier into the CNS and induce the inflammatory process, blocking the IL-2R should have an impact on disease activity in MS. In this trial , a humanized antibody against the IL-2Ra subunit (Zenapax® (Registered Trademark)) will be used to inhibit T cell activation in MS patients who have failed conventional therapy by interferon-b. We will focus on the latter group of patients, since a substantial number of patients on conventional therapy respond only partially or completely fail treatment after longer periods of time. Up to 10 patients fulfilling these criteria will be enrolled in this baseline-to-treatment, cross-over, MRI-controlled single-center phase I/II trial to assess the safety of Zenapax® (Registered Trademark) treatment and, at the same time, examine the clinical course and particularly the inflammatory activity in the CNS by monthly magnetic resonance imaging (MRI). Furthermore, immunological studies will be performed in parallel to the trial in order to a) identify the impact of Zenapax® (Registered Trademark) treatment on immune parameters that should be affected by the blocking of the IL-2R, and b) to improve our understanding of the relevance of activated autoreactive T lymphocytes in MS.
Eligibility:
Study Type: Interventional, Treatment, Safety/Efficacy
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA Between the ages of 18 and 65 years, inclusive. Subjects with relapsing-remitting or secondary progressive Multiple Sclerosis who have had more than 1 relapse within 18 months preceding study enrollment. EDSS score between 2.5 - 6.5, inclusive. Give written informed consent prior to any testing under this protocol, including screening/pre-treatment tests and evaluations that are not considered part of the subject's routine care. Patients who have failed standard IFN-beta therapy. To be eligible to proceed to the treatment phase of the study, subjects must have at least 2 Gd-enhancing lesions or greater in the 3 pre-treatment MRI scans (an average of at least 0.67 Gd-enhancing lesions per scan). EXCLUSION CRITERIA 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. Must not have concurrent, clinically significant (as determined by the investigator) cardiac, immunologic, pulmonary, neurologic, renal, and/or other major disease. No contraindication to monoclonal antibody therapies. Must not be HIV positive. 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 must practice adequate contraception. Female subjects who are not post-menopausal or surgically sterile must be using an acceptable method of contraception. Must not be breastfeeding. 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. Must not have previously participated in this study.
Total Enrollment: 30
Location and Contact Information:
National Institute of Neurological Disorders and Stroke (NINDS) *Recruiting*
Bethesda, Maryland, 20892
United States
Recruiting Patient and Public Liaison Office 1-800-411-1222
Additional Information:
Study ID Numbers: 990169; 99-N-0169
Study Start Date: September 3, 1999
Record last reviewed: October 14, 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001934
Other Multiple Sclerosis Studies:
1. Zenapax to Treat Multiple Sclerosis
2. Auditory Function in Patients With and Without Multiple Sclerosis
3. Safety and Efficacy study of Oral Fampridine-SR on Walking Ability in Multiple Sclerosis
4. Safety and Efficacy of Natalizumab in Combination with Avonex in the Treatment of Multiple Sclerosis
5. Induction Therapy with a Single High Dose Bolus of Intravenous Methotrexate with Leucovorin Rescue, Prior to Initiation of AVONEX® Treatment, in Patients Presenting with a First Acute Demyelinating Event.
Related Studies:
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Other Bethesda Clinical Trials
Zenapax to Treat Multiple Sclerosis
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