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

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: NCT00004833
Recruitment Status : Terminated
First Posted : February 25, 2000
Last Update Posted : April 7, 2015
Information provided by:
FDA Office of Orphan Products Development

Brief Summary:


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.

Condition or disease Intervention/treatment Phase
Guillain-Barre Syndrome Drug: Immune globulin Not Applicable

Detailed Description:


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

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Study Type : Interventional  (Clinical Trial)
Enrollment : 170 participants
Allocation: Randomized
Primary Purpose: Treatment
Study Start Date : July 1995
Study Completion Date : November 2002

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


--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

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): NCT00004833

Sponsors and Collaborators
Emory University
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Study Chair: John T. Sladky Emory University

Layout table for additonal information Identifier: NCT00004833     History of Changes
Other Study ID Numbers: 199/13444
First Posted: February 25, 2000    Key Record Dates
Last Update Posted: April 7, 2015
Last Verified: September 2002

Keywords provided by FDA Office of Orphan Products Development:
Guillain-Barre syndrome
demyelinating neuropathy
neurologic and psychiatric disorders
rare disease

Additional relevant MeSH terms:
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Guillain-Barre Syndrome
Pathologic Processes
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Autoimmune Diseases
Immune System Diseases
Immunoglobulins, Intravenous
Rho(D) Immune Globulin
Immunologic Factors
Physiological Effects of Drugs