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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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 1999 by Office of Rare Diseases (ORD).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Mayo Clinic
Information provided by:
Office of Rare Diseases (ORD)
ClinicalTrials.gov Identifier:
NCT00004645
First received: February 24, 2000
Last updated: June 23, 2005
Last verified: March 1999
History of Changes
  Purpose

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.


Condition Intervention 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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Masking: Double-Blind
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Office of Rare Diseases (ORD):

Estimated Enrollment: 22
Study Start Date: January 1995
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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004645

Sponsors and Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
Mayo Clinic
Investigators
Study Chair: Brian G. Weinshenker Mayo Clinic
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00004645     History of Changes
Other Study ID Numbers: 199/11693, MAYOC-29493
Study First Received: February 24, 2000
Last Updated: June 23, 2005
Health Authority: United States: Federal Government

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
Diffuse Cerebral Sclerosis of Schilder
Demyelinating Diseases
Encephalomyelitis, Acute Disseminated
Encephalomyelitis
Multiple Sclerosis
Myelitis
Myelitis, Transverse
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Brain Diseases
Central Nervous System Diseases
Leukoencephalopathies
 Autoimmune Diseases
Immune System Diseases
Encephalitis
Central Nervous System Infections
Central Nervous System Viral Diseases
Virus Diseases
Spinal Cord Diseases
Paraneoplastic Syndromes, Nervous System
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Paraneoplastic Syndromes
Neurodegenerative Diseases
Optic Neuritis
Optic Nerve Diseases

ClinicalTrials.gov processed this record on May 23, 2013