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Sponsors and Collaborators: |
National Institute of Neurological Disorders and Stroke (NINDS) Mayo Clinic |
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Information provided by: | Office of Rare Diseases (ORD) |
ClinicalTrials.gov Identifier: | NCT00004645 |
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 |
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Acute Disseminated Encephalomyelitis Devic's Syndrome Marburg's Variant of Multiple Sclerosis Balo's Concentric Sclerosis Acute Transverse Myelitis |
Procedure: Plasma exchange |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Efficacy Study |
Estimated Enrollment: | 22 |
Study Start Date: | January 1995 |
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.
Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
--Prior/Concurrent Therapy--
--Patient Characteristics--
Study ID Numbers: | 199/11693, MAYOC-29493 |
Study First Received: | February 24, 2000 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00004645 History of Changes |
Health Authority: | United States: Federal Government |
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 |
Devic Disease Papillitis Spinal Cord Diseases Methylprednisolone Neuromyelitis Optica Balo's Concentric Sclerosis Encephalomyelitis, Acute Disseminated Encephalomyelitis Brain Diseases Neurodegenerative Diseases Neuritis Multiple Sclerosis Optic Nerve Disorder Mental Disorders Myelitis, Transverse |
Autoimmune Diseases of the Nervous System Nervous System Neoplasms Optic Neuritis Autoimmune Diseases Demyelinating Diseases Eye Diseases Rare Diseases Central Nervous System Diseases Sclerosis Diffuse Cerebral Sclerosis of Schilder Encephalitis Virus Diseases Paraneoplastic Syndromes Central Nervous System Infections Demyelinating Autoimmune Diseases, CNS |
Spinal Cord Diseases Neuromyelitis Optica Encephalomyelitis Encephalomyelitis, Acute Disseminated Central Nervous System Viral Diseases Neurodegenerative Diseases Brain Diseases Pathologic Processes Multiple Sclerosis Neoplasms by Site Syndrome Myelitis, Transverse Autoimmune Diseases of the Nervous System Nervous System Neoplasms Optic Neuritis |
Disease Autoimmune Diseases Demyelinating Diseases Immune System Diseases Eye Diseases Nervous System Diseases Central Nervous System Diseases Sclerosis Diffuse Cerebral Sclerosis of Schilder Encephalitis Virus Diseases Neoplasms Paraneoplastic Syndromes Central Nervous System Infections Demyelinating Autoimmune Diseases, CNS |