Phase III Randomized, Double-Blind, Placebo-Controlled Study of Intravenous Immune Globulin for Multiple Sclerosis
Information source: Office of Rare Diseases (ORD)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Multiple Sclerosis
Intervention: immune globulin (Drug)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: National Institute of Neurological Disorders and Stroke (NINDS) Official(s) and/or principal investigator(s):
John H. Noseworthy, Study Chair, Affiliation: Mayo Clinic
Summary
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.
Clinical Details
Study design: Treatment, Randomized, Double-Blind, Placebo Control
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 60 Years.
Gender(s): Both.
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
Locations and Contacts
Additional Information
Starting date: February 1993
Last updated: June 23, 2005
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