NCT04727970

Tricaprilin Infantile Spasms Pilot Study

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Cerecin · Industry
• Sex: All
• Age: 3 Months – 36 Months
• Healthy volunteers: Not accepted

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.

Conditions

• Infantile Spasm

Interventions

Type	Name	Description
DRUG	Tricaprilin	Tricaprilin will be emulsified in infant formula/milk

Timeline

• Start date: 2021-11-01
• Primary completion: 2023-12-04
• Completion: 2023-12-04
• First posted: 2021-01-27
• Last updated: 2024-09-19

Locations

4 sites across 2 countries: Australia, Singapore