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

This study has been completed.

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   

ChemIDplus related topics:   Globulin, Immune    Immunoglobulins   

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

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

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

Study ID Numbers:   199/11660, MAYOC-27992
First Received:   February 24, 2000
Last Updated:   September 2, 2008
ClinicalTrials.gov Identifier:   NCT00004744
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
Multiple Sclerosis
Demyelinating Diseases
Immunoglobulins, Intravenous
Mental Disorders
Rare Diseases
Rho(D) Immune Globulin
Demyelinating Autoimmune Diseases, CNS
Demyelinating diseases
Sclerosis
Autoimmune Diseases of the Nervous System
Immunoglobulins

Additional relevant MeSH terms:
Pathologic Processes
Immunologic Factors
Immune System Diseases
Physiological Effects of Drugs
Nervous System Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 05, 2008




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