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

This study has been terminated.
Information provided by:
FDA Office of Orphan Products Development
ClinicalTrials.gov Identifier:
First received: February 24, 2000
Last updated: April 6, 2015
Last verified: September 2002


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 Intervention
Guillain-Barre Syndrome
Drug: Immune globulin

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by FDA Office of Orphan Products Development:

Estimated Enrollment: 170
Study Start Date: July 1995
Estimated Study Completion Date: November 2002
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


Ages Eligible for Study:   up to 17 Years
Genders Eligible for Study:   Both
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

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Please refer to this study by its ClinicalTrials.gov identifier: NCT00004833

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

No publications provided

ClinicalTrials.gov Identifier: NCT00004833     History of Changes
Other Study ID Numbers: 199/13444, EUSM-076-97, EUSM-FDR001265
Study First Received: February 24, 2000
Last Updated: April 6, 2015
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Guillain-Barre Syndrome
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Demyelinating Diseases
Immune System Diseases
Nervous System Diseases
Neuromuscular Diseases
Peripheral Nervous System Diseases
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 02, 2015