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)

Brief Summary:


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.

Condition or disease Intervention/treatment Phase
Acute Disseminated Encephalomyelitis Devic's Syndrome Marburg's Variant of Multiple Sclerosis Balo's Concentric Sclerosis Acute Transverse Myelitis Procedure: Plasma exchange Phase 3

Detailed 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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 22 participants
Allocation: Randomized
Masking: Double
Primary Purpose: Treatment
Study Start Date : January 1995

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


--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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00004645

Sponsors and Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
Mayo Clinic
Study Chair: Brian G. Weinshenker Mayo Clinic Identifier: NCT00004645     History of Changes
Other Study ID Numbers: 199/11693
First Posted: February 25, 2000    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: March 1999

Keywords provided by Office of Rare Diseases (ORD):
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

Additional relevant MeSH terms:
Neuromyelitis Optica
Multiple Sclerosis
Myelitis, Transverse
Demyelinating Diseases
Encephalomyelitis, Acute Disseminated
Diffuse Cerebral Sclerosis of Schilder
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Autoimmune Diseases
Immune System Diseases
Central Nervous System Infections
Central Nervous System Diseases
Spinal Cord Diseases
Paraneoplastic Syndromes, Nervous System
Nervous System Neoplasms
Neoplasms by Site
Paraneoplastic Syndromes
Neurodegenerative Diseases
Optic Neuritis
Optic Nerve Diseases
Cranial Nerve Diseases
Eye Diseases
Brain Diseases