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Randomized Study of Plasmapheresis or Human Immunoglobulin Infusion in Childhood Guillain-Barre Syndrome

Primary Purpose

Guillain-Barre Syndrome

Status
Terminated
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Immune globulin
Sponsored by
Emory University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Guillain-Barre Syndrome focused on measuring Guillain-Barre syndrome, demyelinating neuropathy, neurologic and psychiatric disorders, rare disease

Eligibility Criteria

undefined - 17 Years (Child)All SexesDoes not accept healthy volunteers

PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Guillain-Barre syndrome (GBS): Progressive weakness of two or more limbs; Absence or reduced tendon reflexes; No atypical symptoms of GBS (e.g., Miller-Fisher variant); No pure sensory neuropathy; No prior history of GBS Disability at least grade 3 according to Guillain-Barre Study Group grading scale (unable to walk 5 meters without assistance); Must not have improvement of one or more disability grades prior to randomization in this study No paresthesias, numbness, or weakness that began more than 14 days before randomization in this study No CNS involvement --Prior/Concurrent Therapy-- Biologic therapy: No prior treatment with plasmapheresis or infusion of human immunoglobulin (IVIg) Endocrine therapy: No concurrent corticosteroids or other immunosuppressants (except for concurrent medical conditions, e.g., asthma) Radiotherapy: Not specified Surgery: Not specified Other: No concurrent mechanical ventilation --Patient Characteristics-- Age: Under 18 but with at least 3 months of independent walking Hematopoietic: Cerebrospinal fluid leukocyte count less than 50/mm3 Hepatic: No liver failure Renal: No kidney failure Neurological: No other major neurologic diseases, other neuromuscular disorders, or cerebral palsy Other: HIV negative; No contraindications to plasmapheresis or IVIg; No severe uncontrolled infection; No known IgA hypersensitivity; No other preexisting disease that would interfere with assessment of disability grades; No other causes of acquired weakness (e.g., poliomyelitis, botulism, or other etiologies); No diabetes; Not pregnant

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    February 24, 2000
    Last Updated
    April 6, 2015
    Sponsor
    Emory University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00004833
    Brief Title
    Randomized Study of Plasmapheresis or Human Immunoglobulin Infusion in Childhood Guillain-Barre Syndrome
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2002
    Overall Recruitment Status
    Terminated
    Study Start Date
    July 1995 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    November 2002 (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Emory University

    4. Oversight

    5. Study Description

    Brief Summary
    OBJECTIVES: I. Compare the efficacy of plasmapheresis and human immunoglobulin infusion in minimizing morbidity and augmenting the pace of recovery in children with Guillain-Barre syndrome. II. Compare the potential risks, in terms of treatment related side effects and adverse clinical outcome, between these two treatment modalities.
    Detailed Description
    PROTOCOL OUTLINE: This is a randomized, multicenter study. Patients are randomized to receive either human immunoglobulin infusion (IVIg) (arm I) or plasmapheresis (arm II). Arm I patients receive liquid heat-treated IVIg for 4 days starting on day 1 and then another single infusion of IVIg on day 7, 8, or 9. Arm II patients receive serial plasmapheresis treatments. The first exchange is given on day 1 and the remaining exchanges are given over the next 5-10 days. Patients are followed at weeks 1, 2, 3, 4, 8, 12, and 24. Completion date provided represents the completion date of the grant per OOPD records

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Guillain-Barre Syndrome
    Keywords
    Guillain-Barre syndrome, demyelinating neuropathy, neurologic and psychiatric disorders, rare disease

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Allocation
    Randomized
    Enrollment
    170 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Immune globulin

    10. Eligibility

    Sex
    All
    Maximum Age & Unit of Time
    17 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Guillain-Barre syndrome (GBS): Progressive weakness of two or more limbs; Absence or reduced tendon reflexes; No atypical symptoms of GBS (e.g., Miller-Fisher variant); No pure sensory neuropathy; No prior history of GBS Disability at least grade 3 according to Guillain-Barre Study Group grading scale (unable to walk 5 meters without assistance); Must not have improvement of one or more disability grades prior to randomization in this study No paresthesias, numbness, or weakness that began more than 14 days before randomization in this study No CNS involvement --Prior/Concurrent Therapy-- Biologic therapy: No prior treatment with plasmapheresis or infusion of human immunoglobulin (IVIg) Endocrine therapy: No concurrent corticosteroids or other immunosuppressants (except for concurrent medical conditions, e.g., asthma) Radiotherapy: Not specified Surgery: Not specified Other: No concurrent mechanical ventilation --Patient Characteristics-- Age: Under 18 but with at least 3 months of independent walking Hematopoietic: Cerebrospinal fluid leukocyte count less than 50/mm3 Hepatic: No liver failure Renal: No kidney failure Neurological: No other major neurologic diseases, other neuromuscular disorders, or cerebral palsy Other: HIV negative; No contraindications to plasmapheresis or IVIg; No severe uncontrolled infection; No known IgA hypersensitivity; No other preexisting disease that would interfere with assessment of disability grades; No other causes of acquired weakness (e.g., poliomyelitis, botulism, or other etiologies); No diabetes; Not pregnant
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    John T. Sladky
    Organizational Affiliation
    Emory University
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

    Randomized Study of Plasmapheresis or Human Immunoglobulin Infusion in Childhood Guillain-Barre Syndrome

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