Phase III Randomized, Double-Blind, Placebo-Controlled Study of Intravenous Immune Globulin for Multiple Sclerosis

Multiple Sclerosis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00004744
• Other study ID #: 199/11660
• Secondary ID: MAYOC-27992
• Status: Completed
• Phase: Phase 3
• First received: February 24, 2000
• Last updated: September 8, 2008
• Start date: February 1993

Study information

• Verified date: September 2008
• Source: Office of Rare Diseases (ORD)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. primary completion date: September 1998
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• immune globulin

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
National Institute of Neurological Disorders and Stroke (NINDS)	Mayo Clinic