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

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

This study is ongoing, but not recruiting participants.
Information provided by Office of Rare Diseases (ORD)

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

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

Official Title ^†

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.

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 Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double-Blind, Placebo Control

Primary Outcome Measure ^†

Secondary Outcome Measure ^†

Condition ^†

Multiple Sclerosis

Intervention ^†

Drug: immune globulin

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Active, not recruiting

Enrollment ^†

Start Date ^†

February 1993

Completion Date

Eligibility 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

Gender

Both

Ages

18 Years to 60 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Administrative Information Fields

NCT ID ^†

NCT00004744

Organization ID

199/11660

Secondary IDs ^††

MAYOC-27992

Study Sponsor ^†

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborators ^††

Mayo Clinic

Investigators ^†

Study Chair:

John H. Noseworthy

Mayo Clinic

Information Provided By

Office of Rare Diseases (ORD)

Verification Date

January 1998

First Received Date ^†

February 24, 2000

Last Updated Date

June 23, 2005

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.