Acute Disseminated Encephalomyelitis Clinical Trial
Verified date | March 1999 |
Source | Office of Rare Diseases (ORD) |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 22 |
Est. completion date | |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 60 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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National Institute of Neurological Disorders and Stroke (NINDS) | Mayo Clinic |
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