Full Text View
Tabular View
No Study Results Posted
Related Studies
Phase III Randomized, Double-Blind, Placebo-Controlled Study of Intravenous Immune Globulin for Multiple Sclerosis
This study has been completed.
First Received: February 24, 2000   Last Updated: September 8, 2008   History of Changes
Sponsors and Collaborators: National Institute of Neurological Disorders and Stroke (NINDS)
Mayo Clinic
Information provided by: Office of Rare Diseases (ORD)
ClinicalTrials.gov Identifier: NCT00004744
  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 III

MedlinePlus related topics: Multiple Sclerosis
Drug Information available for: Immunoglobulins Globulin, Immune
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control

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
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

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

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

Study placed in the following topic categories:
Autoimmune Diseases
Demyelinating Diseases
Immunologic Factors
Rare Diseases
Sclerosis
Antibodies
Multiple Sclerosis
Mental Disorders
Immunoglobulins, Intravenous
Demyelinating Autoimmune Diseases, CNS
Rho(D) Immune Globulin
Autoimmune Diseases of the Nervous System
Immunoglobulins

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

ClinicalTrials.gov processed this record on May 07, 2009