Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06525649
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-15
Brief Title:
A Double Blind Randomized Cross-over Study Examining the Suppression of the Photoparoxysmal EEG Response With NPT 2042
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Double Blind Randomized Cross-over Study Examining the Suppression of the Photoparoxysmal EEG Response With NPT 2042
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A double-blind placebo-controlled crossover trial to investigate the PPR of approximately 5 subjects with a known stable PPR on EEG using 2 doses of NPT 2042 compared to placebo
Detailed Description:
This study will compare the effect of 2 doses of NPT 2042 on the photoparoxysmal- electroencephalogram EEG response PPR compared to placebo Subjects will be screened to ensure they have a stable PPR Subjects will then return for 3 treatment visits each lasting 1 day with minimum 14-day washout period between visits Subjects will be randomized to a treatment sequence in order to receive NPT 2042 160 mg or 240 mg or matching placebo on each treatment day The PPR will be measured at predose -05 hours and 05 1 2 3 4 and 6 hours postdose The PPR of the active treatments will be compared to the placebo response
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