- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00004744
Phase III Randomized, Double-Blind, Placebo-Controlled Study of Intravenous Immune Globulin for Multiple Sclerosis
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.
Study Overview
Detailed Description
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.
Study Type
Enrollment
Phase
- Phase 3
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Masking: Double
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: John H. Noseworthy, Mayo Clinic
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Nervous System Diseases
- Immune System Diseases
- Demyelinating Autoimmune Diseases, CNS
- Autoimmune Diseases of the Nervous System
- Demyelinating Diseases
- Autoimmune Diseases
- Multiple Sclerosis
- Sclerosis
- Physiological Effects of Drugs
- Immunologic Factors
- Antibodies
- Immunoglobulins
- Immunoglobulins, Intravenous
- gamma-Globulins
- Rho(D) Immune Globulin
Other Study ID Numbers
- 199/11660
- MAYOC-27992
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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