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Phase 3
18 Years
60 Years
Open (Enrolling)
Acute Disseminated Encephalomyelitis, Devic's Syndrome, Marburg's Variant of Multiple Sclerosis, Balo's Concentric Sclerosis, Acute Transverse Myelitis

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Trial Information

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

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

Patients are followed at 1 and 6 months after the last exchange.

Inclusion 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

- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Masking: Double-Blind, Primary Purpose: Treatment

Principal Investigator

Brian G. Weinshenker

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic


United States: Federal Government

Study ID:




Start Date:

January 1995

Completion Date:

Related Keywords:

  • Acute Disseminated Encephalomyelitis
  • Devic's Syndrome
  • Marburg's Variant of Multiple Sclerosis
  • Balo's Concentric Sclerosis
  • Acute Transverse Myelitis
  • 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
  • Diffuse Cerebral Sclerosis of Schilder
  • Demyelinating Diseases
  • Encephalomyelitis, Acute Disseminated
  • Encephalomyelitis
  • Multiple Sclerosis
  • Myelitis
  • Myelitis, Transverse
  • Neuromyelitis Optica
  • Sclerosis