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

This study has been completed.
Sponsor:
Collaborator:
Mayo Clinic
Information provided by:
Office of Rare Diseases (ORD)
ClinicalTrials.gov Identifier:
NCT00004744
First received: February 24, 2000
Last updated: September 8, 2008
Last verified: September 2008
  Purpose

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 Intervention Phase
Multiple Sclerosis
Drug: immune globulin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double-Blind
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Office of Rare Diseases (ORD):

Estimated Enrollment: 76
Study Start Date: February 1993
Primary Completion Date: September 1998 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004744

Sponsors and Collaborators
Mayo Clinic
Investigators
Study Chair: John H. Noseworthy Mayo Clinic
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00004744     History of Changes
Other Study ID Numbers: 199/11660, MAYOC-27992
Study First Received: February 24, 2000
Last Updated: September 8, 2008
Health Authority: United States: Federal Government

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

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

ClinicalTrials.gov processed this record on August 28, 2014