Ignite Creation Date:
2024-05-05 @ 9:30 PM
Last Modification Date:
2024-10-26 @ 10:05 AM
Study NCT ID:
NCT00894010
Status:
COMPLETED
Last Update Posted:
2012-03-05
First Post:
2009-05-05
Brief Title:
Photosensitivity Proof of Concept Trial
Sponsor:
The Epilepsy Study Consortium
Organization:
The Epilepsy Study Consortium
Study Overview
Official Title:
Assessment of Marketed AEDs in the Human Photosensitivity Proof of Concept Trial
Status:
COMPLETED
Status Verified Date:
2012-03
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:
The purpose of this study is to determine whether patients who usually have abnormal electrical EEG responses when shown flashing lights will show a reduction in abnormal electrical activity when they take a single dose of 2 marketed drugs carbamazepine and levetiracetam If so a similar study in the future may be able to identify promising new drugs for epilepsy
Patients who successfully complete the screening visit will return 4 additional times and will receive either placebo 2 times or a single oral dose of both carbamazepine 400mg and levetiracetam 1000mg in random order
During each of the study days several procedures and intermittent photosensitivity IPS assessments will be performed at 5 pre-determined times over the course of the day one pre-dose and 4 post-dose
Patients who successfully complete the screening visit will return 4 additional times and will receive either placebo 2 times or a single oral dose of both carbamazepine 400mg and levetiracetam 1000mg in random order
During each of the study days several procedures and intermittent photosensitivity IPS assessments will be performed at 5 pre-determined times over the course of the day one pre-dose and 4 post-dose
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None