Tricaprilin Infantile Spasms Pilot Study

Infantile Spasm Clinical Trial

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 Active, not recruiting

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04727970
Study type	Interventional
Source	Cerecin
Contact
Status	Active, not recruiting
Phase	Phase 1
Start date	November 1, 2021
Completion date	January 2025

View Details

See also
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Suspended	`NCT03347526` - A Novel Approach to Infantile Spasms	Phase 3
Recruiting	`NCT03876444` - Intravenous Methylprednisolone Versus Oral Prednisolone for Infantile Spasms	Phase 2/Phase 3