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Leucine Enriched Essential Amino Acid Powder as an Add-on to a Classic Ketogenic Diet in Refractory Epilepsy

NCT06387186 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2026-05-22

No results posted yet for this study

Summary

The main purpose of this study is to evaluate the safety and tolerability of a Leucine-Enriched Essential Amino Acid (LEAA) Powder as an add-on to a classic ketogenic diet (KD) in pediatric and adult patients with refractory epilepsy.

Conditions

  • Refractory Epilepsy
  • Drug Resistant Epilepsy

Interventions

DRUG

Leucine-Enriched Essential Amino Acid powder

Leucine-Enriched Essential Amino Acid Powder will be orally/enterally administered by mixing in water or ketogenic formula.

Sponsors & Collaborators

  • Ajinomoto USA, INC.

    collaborator INDUSTRY

  • Ajinomoto Co., Inc.

    collaborator INDUSTRY

  • Elizabeth Anne Thiele

    lead OTHER

Principal Investigators

  • Elizabeth Thiele, MD, PhD · Massachusetts General Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-10
Primary Completion
2026-02-18
Completion
2026-02-18
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT06387186 on ClinicalTrials.gov