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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

Page last updated: June 20, 2008

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