Ignite Creation Date:
2024-05-06 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 1:55 PM
Study NCT ID:
NCT04727970
Status:
COMPLETED
Last Update Posted:
2023-07-27
First Post:
2021-01-19
Brief Title:
Tricaprilin Infantile Spasms Pilot Study
Sponsor:
Cerecin
Organization:
Cerecin
Study Overview
Official Title:
A Phase I Open-Label Pilot Study to Investigate the Feasibility Safety Tolerability and Efficacy of Daily Administration of Tricaprilin in Subjects with Infantile Spasms
Status:
COMPLETED
Status Verified Date:
2024-04
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 assess the safety tolerability and efficacy of tricaprilin in subjects with infantile spasms This is a single-arm open-label pilot study in up to 10 subjects with infantile spasms
Upon completion of the main phase subjects who exhibit improvement in seizure control and who tolerate the compound will be offered continued use of the IMP until benefit-risk ratio is no longer favourable in a one-year open-label extension phase available to Australian participants only
Upon completion of the main phase subjects who exhibit improvement in seizure control and who tolerate the compound will be offered continued use of the IMP until benefit-risk ratio is no longer favourable in a one-year open-label extension phase available to Australian participants only
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None