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Tricaprilin Infantile Spasms Pilot Study

NCT04727970 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2024-09-19

No results posted yet for this study

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

DRUG

Tricaprilin

Tricaprilin will be emulsified in infant formula/milk

Sponsors & Collaborators

  • Cerecin

    lead INDUSTRY

Principal Investigators

  • Study Director · Cerecin

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
3 Months
Max Age
36 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-01
Primary Completion
2023-12-04
Completion
2023-12-04

Countries

  • Australia
  • Singapore

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04727970 on ClinicalTrials.gov