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

NCT00004833 | Terminated

• 3 other identifiers: 199/13444EUSM-076-97EUSM-FDR001265
• Study Type: interventional
• Target: 170
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Guillain-Barre Syndrome

Keywords

Guillain-Barre syndrome; demyelinating neuropathy; neurologic and psychiatric disorders; rare disease

Interventions

Immune globulin DRUG

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Emory University: lead

MeSH Terms

Conditions

Guillain-Barre Syndrome; Neurologic Manifestations; Mental Disorders; Rare Diseases

Interventions

Immunoglobulins

Condition Hierarchy (Ancestors)

Polyradiculoneuropathy; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Polyneuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Autoimmune Diseases; Immune System Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• John T. Sladky

  Emory University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 24, 2000
• First Posted: February 25, 2000
• Study Start: July 1, 1995
• Study Completion: November 1, 2002
• Last Updated: April 7, 2015

Record last verified: 2002-09