Phase III Randomized, Double-Blind, Sham-Controlled Study of Plasma Exchange for Acute Severe Attacks of Inflammatory Demyelinating Disease Refractory to Intravenous Methylprednisolone

NCT00004645 | Unknown Phase 3

• 2 other identifiers: 199/11693MAYOC-29493
• Study Type: interventional
• Target: 22
• Locations: 0 countries
• Sites: N/A

Brief Summary

OBJECTIVES: I. Evaluate the effectiveness of plasma exchange in the treatment of acute severe attacks of inflammatory demyelinating disease in patients who have failed intravenous steroid therapy.

Conditions

Acute Disseminated Encephalomyelitis; Devic's Syndrome; Marburg's Variant of Multiple Sclerosis; Balo's Concentric Sclerosis; Acute Transverse Myelitis

Keywords

Balo's concentric sclerosis; Devic's syndrome; Marburg's variant of multiple sclerosis; acute disseminated encephalomyelitis; acute transverse myelitis; multiple sclerosis; neurologic and psychiatric disorders; rare disease

Interventions

Plasma exchange PROCEDURE

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- * Idiopathic inflammatory demyelinating syndrome, as follows: biopsy-proven if necessary - established diagnosis of multiple sclerosis (MS) using Poser criteria; acute disseminated encephalomyelitis; Marburg's variant of MS Balo's concentric sclerosis * Eligible without biopsy: acute transverse myelitis; Devic's syndrome * Acute neurologic deficit markedly affecting consciousness, language, or brainstem/spinal cord function, i.e., aphasia, paraplegia, coma, quadriplegia, hemiplegia, severe organic brain syndrome * Deficit unresponsive to 5 days of high-dose intravenous methylprednisolone (MePRDL), as follows: deficit duration of 21 days to 3 months AND no improvement 14 days after beginning MePRDL OR deficit duration of 12 to 20 days AND continued deterioration after completion of MePRDL * No chronically progressive demyelinating disease * No HIV-associated demyelinating syndrome * No progressive multifocal leukoencephalopathy * No optic neuritis --Prior/Concurrent Therapy-- * No more than 3 months of prior steroid therapy Failure on prior MePRDL required Minimum dose 7 mg/kg per day for 5 days * At least 6 weeks since other immunosuppressives, e.g., cyclophosphamide, azathioprine, cyclosporine --Patient Characteristics-- * Renal: Creatinine less than 1.5 mg/dL * Cardiovascular: No hypovolemia; no infarction; no vasculitis; no other major systemic cardiovascular illness * Pulmonary: No major respiratory illness * Other: No infection, including hepatitis or human immunodeficiency virus; no recent intravenous drug abuse; no high-risk sexual behavior; no cardiac, cerebrovascular, or autonomic dysfunction that would increase risk of hypotension; no other major systemic illness that would preclude protocol therapy; no pregnant or nursing women; negative serum pregnancy test required of fertile women; effective contraception required

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

Sponsors & Collaborators

• National Institute of Neurological Disorders and Stroke (NINDS): lead
• Mayo Clinic: collaborator

MeSH Terms

Conditions

Encephalomyelitis, Acute Disseminated; Neuromyelitis Optica; Diffuse Cerebral Sclerosis of Schilder; Myelitis, Transverse; Multiple Sclerosis; Neurologic Manifestations; Mental Disorders; Rare Diseases

Interventions

Plasma Exchange

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Leukoencephalopathies; Brain Diseases; Central Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Optic Neuritis; Optic Nerve Diseases; Cranial Nerve Diseases; Eye Diseases; Myelitis; Central Nervous System Infections; Infections; Paraneoplastic Syndromes, Nervous System; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Paraneoplastic Syndromes; Spinal Cord Diseases; Neurodegenerative Diseases; Neuroinflammatory Diseases; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Blood Transfusion; Biological Therapy; Therapeutics; Plasmapheresis; Blood Component Removal; Sorption Detoxification; Extracorporeal Circulation; Surgical Procedures, Operative

Study Officials

• Brian G. Weinshenker

  Mayo Clinic

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: February 24, 2000
• First Posted: February 25, 2000
• Study Start: January 1, 1995
• Last Updated: June 24, 2005

Record last verified: 1999-03