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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00004645
Recruitment Status : Unknown
Verified March 1999 by Office of Rare Diseases (ORD).
Recruitment status was:  Active, not recruiting
First Posted : February 25, 2000
Last Update Posted : June 24, 2005
Mayo Clinic
Information provided by:
Office of Rare Diseases (ORD)

February 24, 2000
February 25, 2000
June 24, 2005
January 1995
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No Changes Posted
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Phase III Randomized, Double-Blind, Sham-Controlled Study of Plasma Exchange for Acute Severe Attacks of Inflammatory Demyelinating Disease Refractory to Intravenous Methylprednisolone
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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.

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.

Phase 3
Allocation: Randomized
Masking: Double
Primary Purpose: Treatment
  • Acute Disseminated Encephalomyelitis
  • Devic's Syndrome
  • Marburg's Variant of Multiple Sclerosis
  • Balo's Concentric Sclerosis
  • Acute Transverse Myelitis
Procedure: Plasma exchange
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
Same as current
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--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
Sexes Eligible for Study: All
18 Years to 60 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
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National Institute of Neurological Disorders and Stroke (NINDS)
Mayo Clinic
Study Chair: Brian G. Weinshenker Mayo Clinic
Office of Rare Diseases (ORD)
March 1999

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP