Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004645
Status:
UNKNOWN
Last Update Posted:
2005-06-24
First Post:
2000-02-24
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
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
Office of Rare Diseases ORD
Study Overview
Official Title:
None
Status:
UNKNOWN
Status Verified Date:
1999-03
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| MAYOC-29493 | None | None | None |