Ignite Creation Date:
2024-05-05 @ 9:53 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004776
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
2000-02-24
Brief Title:
Phase III Randomized Double-Blind Placebo-Controlled Study of Oral Topiramate for Lennox-Gastaut Syndrome
Sponsor:
National Center for Research Resources NCRR
Organization:
Office of Rare Diseases ORD
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2001-12
Last Known Status:
None
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 safety and efficacy of oral topiramate in patients with Lennox-Gastaut syndrome
I Evaluate the safety and efficacy of oral topiramate in patients with Lennox-Gastaut syndrome
Detailed Description:
PROTOCOL OUTLINE This is a randomized double-blind study Following a 28-day baseline period patients are randomly assigned to oral topiramate or placebo The dose of study medication is titrated over the first 3 weeks the maintenance dose is administered for the next 5 weeks
Extended topiramate treatment is available to all patients after randomized therapy
Extended topiramate treatment is available to all patients after randomized therapy
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 |
|---|---|---|---|
| UCLA-567 | None | None | None |