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

Brief Title

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


Brief Summary

      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.
    

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 Phase

Phase 3

Study Type

Interventional




Condition

Acute Disseminated Encephalomyelitis

Intervention

Plasma exchange


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

22

Start Date

January 1995



Eligibility 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
      

Gender

All

Ages

18 Years - 60 Years

Accepts Healthy Volunteers

No

Contacts

Brian G. Weinshenker, , 



Administrative Informations


NCT ID

NCT00004645

Organization ID

199/11693

Secondary IDs

MAYOC-29493


Study Sponsor

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborators

 Mayo Clinic

Study Sponsor

Brian G. Weinshenker, Study Chair, Mayo Clinic


Verification Date

March 1999