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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00004744
Recruitment Status : Completed
First Posted : February 25, 2000
Last Update Posted : September 9, 2008
Mayo Clinic
Information provided by:
Office of Rare Diseases (ORD)

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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Drug: immune globulin Phase 3

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 Type : Interventional  (Clinical Trial)
Enrollment : 76 participants
Allocation: Randomized
Masking: Double
Primary Purpose: Treatment
Study Start Date : February 1993
Actual Primary Completion Date : September 1998

Resource links provided by the National Library of Medicine

Drug Information available for: Rhophylac
U.S. FDA Resources

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


--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


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00004744

Sponsors and Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
Mayo Clinic
Study Chair: John H. Noseworthy Mayo Clinic Identifier: NCT00004744     History of Changes
Other Study ID Numbers: 199/11660
First Posted: February 25, 2000    Key Record Dates
Last Update Posted: September 9, 2008
Last Verified: September 2008

Keywords provided by Office of Rare Diseases (ORD):
multiple sclerosis
neurologic and psychiatric disorders
rare disease

Additional relevant MeSH terms:
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Immunoglobulins, Intravenous
Rho(D) Immune Globulin
Immunologic Factors
Physiological Effects of Drugs