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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT00004645
Other study ID # 199/11693
Secondary ID MAYOC-29493
Status Active, not recruiting
Phase Phase 3
First received February 24, 2000
Last updated June 23, 2005
Start date January 1995

Study information

Verified date March 1999
Source Office of Rare Diseases (ORD)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 22
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 60 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Masking: Double-Blind, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
Plasma exchange


Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
National Institute of Neurological Disorders and Stroke (NINDS) Mayo Clinic
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