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

NCT00004744 | Completed Phase 3

• 2 other identifiers: 199/11660MAYOC-27992
• Study Type: interventional
• Target: 76
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Multiple Sclerosis

Keywords

multiple sclerosis; neurologic and psychiatric disorders; rare disease

Interventions

immune globulin DRUG

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Institute of Neurological Disorders and Stroke (NINDS): lead
• Mayo Clinic: collaborator

MeSH Terms

Conditions

Multiple Sclerosis; Neurologic Manifestations; Mental Disorders; Rare Diseases

Interventions

Immunoglobulins

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes

Intervention Hierarchy (Ancestors)

Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• John H. Noseworthy

  Mayo Clinic

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: February 24, 2000
• First Posted: February 25, 2000
• Study Start: February 1, 1993
• Primary Completion: September 1, 1998
• Last Updated: September 9, 2008

Record last verified: 2008-09