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

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators:	National Institute of Neurological Disorders and Stroke (NINDS) Mayo Clinic
Information provided by:	Office of Rare Diseases (ORD)
ClinicalTrials.gov Identifier:	NCT00004645

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 III

MedlinePlus related topics: Multiple Sclerosis

Drug Information available for: Methylprednisolone

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Efficacy Study

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

Study ID Numbers:	199/11693, MAYOC-29493
Study First Received:	February 24, 2000
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00004645
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

Study placed in the following topic categories:

Acute disseminated encephalomyelitis
Papillitis
Spinal Cord Diseases
Methylprednisolone
Neuromyelitis Optica
Demyelinating diseases
Encephalomyelitis, Acute Disseminated
Encephalomyelitis
Brain Diseases
Neurodegenerative Diseases
Neuritis
Multiple Sclerosis
Mental Disorders
Myelitis, Transverse
Autoimmune Diseases of the Nervous System

Nervous System Neoplasms
Optic Neuritis
Devic disease
Autoimmune Diseases
Demyelinating Diseases
Eye Diseases
Rare Diseases
Central Nervous System Diseases
Sclerosis
Diffuse Cerebral Sclerosis of Schilder
Optic nerve disorder
Encephalitis
Virus Diseases
Balo disease
Paraneoplastic Syndromes

Additional relevant MeSH terms:

Neoplasms
Disease
Pathologic Processes
Neoplasms by Site
Immune System Diseases

Syndrome
Nervous System Diseases
Central Nervous System Viral Diseases
Cranial Nerve Diseases

ClinicalTrials.gov processed this record on January 16, 2009