Phase III Randomized, Double-Blind, Sham-Controlled Study of Plasma Exchange for Acute Severe Attacks of Inflammatory Demyelinating Disease Refractory to Intravenous Methylprednisolone
This trial is active, not recruiting.
|Conditions||acute disseminated encephalomyelitis, devic's syndrome, marburg's variant of multiple sclerosis, balo's concentric sclerosis, acute transverse myelitis|
|Sponsor||National Institute of Neurological Disorders and Stroke (NINDS)|
|Start date||January 1995|
|Trial size||22 participants|
|Trial identifier||NCT00004645, 199/11693, MAYOC-29493|
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.
|Endpoint classification||efficacy study|
Male or female participants from 18 years up to 60 years old.
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
|Description||PROTOCOL OUTLINE: This is a randomized, double-blind study. Patients are stratified by disease type; each stratum is randomized separately. The first group of patients receives a true plasma exchange using continuous-flow centrifugation with serum albumin and crystalloid replacement every 2 days for a total of 7 exchanges. The second group receives a sham plasma exchange with no centrifugation every 2 days for a total of 7 exchanges. Patients cross to the alternate therapy if there is less than a moderate improvement by day 14. The treatment decision is based on a blinded neurologic assessment. Concurrent corticosteroids and other immunosuppressants, and high-dose barbiturates are not allowed. Patients are followed at 1 and 6 months after the last exchange.|
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