Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06534502
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-30
Brief Title:
Study of the Pharmacokinetics Safety and Tolerability of ZONISADE in Children 1 Month to 17 Years of Age With Partial-onset Seizures
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Study to Evaluate the Pharmacokinetics Safety and Tolerability of Zonisamide Oral Suspension 100 mg5 ml to Determine a Dosing Regimen in Children 1 Month to 17 Years of Age With Partial-onset Seizures
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
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:
The purpose of this research is to determine the optimal dose safety and tolerability of zonisamide oral suspension in children ages 1 month to 17 years of age who have partial-onset focal seizures The study consists of four periods a Screening Period about 14 days a Titration Period 8 weeks a Maintenance Period 4 weeks and a Follow-Up Period 1 week
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