Trials / Unknown
UnknownNCT00004645
Phase III Randomized, Double-Blind, Sham-Controlled Study of Plasma Exchange for Acute Severe Attacks of Inflammatory Demyelinating Disease Refractory to Intravenous Methylprednisolone
- Status
- Unknown
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 22 (planned)
- Sponsor
- National Institute of Neurological Disorders and Stroke (NINDS) · NIH
- Sex
- All
- Age
- 18 Years – 60 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Acute Disseminated Encephalomyelitis
- Devic's Syndrome
- Marburg's Variant of Multiple Sclerosis
- Balo's Concentric Sclerosis
- Acute Transverse Myelitis
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Plasma exchange |
Timeline
- Start date
- 1995-01-01
- First posted
- 2000-02-25
- Last updated
- 2005-06-24
Source: ClinicalTrials.gov record NCT00004645. Inclusion in this directory is not an endorsement.