clinical trial · NCT04727970
Tricaprilin Infantile Spasms Pilot Study
Cerecin·phase1·completed·n = 8
Infantile SpasmTricaprilin
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.
started
Nov 1, 2021
primary completion
Dec 4, 2023
completion
Dec 4, 2023
last updated
Sep 19, 2024
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
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol