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

This study has suspended participant recruitment.
Sponsor:
Collaborator:
Emory University
Information provided by:
FDA Office of Orphan Products Development
ClinicalTrials.gov Identifier:
NCT00004833
First received: February 24, 2000
Last updated: June 23, 2005
Last verified: September 2002
  Purpose

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.


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
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.

  Eligibility

Ages Eligible for Study:   up to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Sponsors and Collaborators
Emory University
Investigators
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: June 23, 2005
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
Polyradiculoneuropathy
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Polyneuropathies
Autoimmune Diseases
Immune System Diseases
Antibodies
Immunoglobulins
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 26, 2014