Ignite Creation Date:
2025-12-24 @ 8:03 PM
Ignite Modification Date:
2025-12-25 @ 5:36 PM
Study NCT ID:
NCT00979004
Status:
TERMINATED
Last Update Posted:
2012-10-04
First Post:
2009-09-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Investigate the Effect of ICA-105665 in Photosensitive Epilepsy Patients
Sponsor:
Pfizer
Organization:
Study Overview
Official Title:
A Phase 2, Multi-Center, Single-Blind, Placebo-Controlled Pharmacodynamic Evaluation of ICA-105665 in Epilepsy Patients With a Photo-Induced Paroxysmal EEG Response
Status:
TERMINATED
Status Verified Date:
2012-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study was terminated on September 12, 2010 per protocol following a serious adverse event that occurred with the first subject dosed at 600 mg.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Subjects with epilepsy with a documented photoparoxysmal response to intermittent photic stimulation (IPS) will participate. Four subjects will be enrolled at each dose level and will receive a single dose of placebo and a single dose of ICA-105665 during the study, each followed by intermittent photic stimulation. The effects of ICA-105665 on the photoparoxysmal electroencephalography (EEG) response of each group will be reviewed before the dose is selected for each subsequent group of subjects.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| B5311005 | None | None | View |