Phase III Randomized, Double-Blind, Sham-Controlled Study of Plasma Exchange for Acute Severe Att… (NCT00004645) | Clinical Trial Compass
UnknownPhase 3
Phase III Randomized, Double-Blind, Sham-Controlled Study of Plasma Exchange for Acute Severe Attacks of Inflammatory Demyelinating Disease Refractory to Intravenous Methylprednisolone
22 participantsStarted 1995-01
Plain-language 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.
Who can participate
Age range18 Years – 60 Years
SexALL
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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
* Othe…
Trial details
NCT IDNCT00004645
SponsorNational Institute of Neurological Disorders and Stroke (NINDS)