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Phase III Randomized, Double-Blind, Placebo-Controlled Study of Intravenous Immune Globulin for Multiple Sclerosis Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for proven healthcare advice, travels to or treatment by using a genuine medical doctor. We are not physicians. Always confer with your doctor on Phase III Randomized, Double-Blind, Placebo-Controlled Study of Intravenous Immune Globulin for Multiple Sclerosis conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Phase III Randomized, Double-Blind, Placebo-Controlled Study of Intravenous Immune Globulin for Multiple Sclerosis Clinical research trials and Phase III Randomized, Double-Blind, Placebo-Controlled Study of Intravenous Immune Globulin for Multiple Sclerosis healthcare trials take place in many of cities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectiveness of new drugs. The function of the studies / undertakings is to answer specific human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector companies to find treatments for all forms of conditions, including Phase III Randomized, Double-Blind, Placebo-Controlled Study of Intravenous Immune Globulin for Multiple Sclerosis. Phase III Randomized, Double-Blind, Placebo-Controlled Study of Intravenous Immune Globulin for Multiple Sclerosis Clinical Trials and other clinical trials allow for volunteers to access medical treatment alternatives before they are available to the masses. Many times the test subjects undergo treatment for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Phase III Randomized, Double-Blind, Placebo-Controlled Study of Intravenous Immune Globulin for Multiple Sclerosis clinical trial. Test subjects oftentimes recieve the best healthcare possible for their Phase III Randomized, Double-Blind, Placebo-Controlled Study of Intravenous Immune Globulin for Multiple Sclerosis condition. Hazards are a reality, nonetheless, and might include additional or frequent doctor trips, healthcare 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 > "P" Clinical Trials Conditions > Phase III Randomized, Double-Blind, Placebo-Controlled Study of Intravenous Immune Globulin for Multiple Sclerosis  Phase III Randomized, Double-Blind, Placebo-Controlled Study of Intravenous Immune Globulin for Multiple Sclerosis
Phase III Randomized, Double-Blind, Placebo-Controlled Study of Intravenous Immune Globulin for Multiple Sclerosis
For Condition: Multiple Sclerosis
Status: No longer recruiting
Sponsor(s): National Institute of Neurological Disorders and Stroke (NINDS) , Mayo Clinic
Synopsis: OBJECTIVES: I. Determine whether high-dose intravenous immune globulin (IVIG) is more effective than placebo in restoring neurologic function (muscle strength) in patients with multiple sclerosis. II. Determine the time to recovery following IVIG.
Details: PROTOCOL OUTLINE: This is a randomized, double-blind study. Patients are treated with intravenous immune globulin or placebo. In the absence of a hypersensitivity reaction to a test dose, a total of 11 doses is administered: daily for 5 days, then every 2 weeks for 12 weeks. Patients are followed at 3 months.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control
Minimum Age/Maximum Age: 18 Years/60 Years
Genders: Both
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Clinically or laboratory-supported definite multiple sclerosis - Disease relapsing-remitting or relapsing-progressive (i.e., secondary- progressive) - Targeted neurologic deficit as follows: 25% or more loss of power in at least 1 limb Severity -1 or greater on Mayo Clinic rating scale OR Between 3+/5 and 4-/5 on Medical Research Clinic muscle power scale - Documented by Mayo Clinic Department of Neurology as neither progressing nor improving for 4 to 18 months prior to entry No clinical evidence of spontaneous or corticosteroid-induced improvement - Able to cooperate with isometric strength testing requirements --Prior/Concurrent Therapy-- - No concurrent experimental drug therapy - No concurrent intravenous immune globulin At least 3 months since immunosuppressive therapy, e.g., corticosteroids and corticotropin - At least 3 months since plasma exchange --Patient Characteristics-- - Hepatic: No coagulation defect, e.g., hyperviscosity syndrome - Renal: Creatinine no greater than 1.5 times normal - Cardiovascular: No unstable or advanced ischemic or cerebrovascular disease, e.g.: angina congestive heart failure transient ischemic attack stroke - Immunologic: No human gamma globulin or albumin sensitivity No hypergammaglobulinemia No known antibody deficiency syndrome, especially IgA deficiency Other: - No condition interfering with neurologic exam, e.g.: - Major amputation - Deforming arthritis - Major psychiatric illness - Superimposed lower motor neuron deficit - No intellectual impairment precluding study participation - No pregnant or nursing women - Adequate contraception required of fertile patients
Total Enrollment: 76
Location and Contact Information:
Overall Study Official:
JohnNoseworthy, Study Chair, Mayo Clinic
Additional Information:
Study ID Numbers: 199/11660; MAYOC-27992
Study Start Date: February 1993
Record last reviewed: January 1998
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004744
Other Multiple Sclerosis Studies:
1. A study to evaluate the preliminary efficacy pharmacokinetics and immunogenicity of BMS-188667 administered to subjects with relapsing-remitting multiple sclerosis
2. Evaluation of Lyme Disease: Clinical, Microbiological and Immunological Characteristics
3. Combination Therapy with Avonex and BiMonthly High Dose Intravenous Methotrexate in Multiple Sclerosis
4. Antibiotic treatment trial directed against Chlamydia pneumonia in multiple sclerosis
5. Assessment of Patients with Multiple Sclerosis (MS)
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Phase III Randomized, Double-Blind, Placebo-Controlled Study of Intravenous Immune Globulin for Multiple Sclerosis
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