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

Completed · Phase 1

Conditions studied: Refractory Epilepsy, Drug Resistant Epilepsy

In brief

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.

Key facts

Study ID

NCT06387186

Run by

Elizabeth Anne Thiele

People needed

4

Starts

2024-05-10

Expected to finish

2026-02-18

Last updated by the study team

2026-05-22

Who can join

Age: 2 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female patients ages 2 years and up at enrollment.
• A diagnosis of epilepsy, with at least 2 seizures per week according to the parent/guardian report to study staff and investigator medical notes if applicable. All seizure types allowed.
• Under stable treatment with a classic ketogenic diet (KD) regimen with a KD ratio ≥ 1:1, with or without antiseizure medications (ASMs), for at least 28 days with documented, partial response (≥40% reduction in seizures), but not a complete response (<90% reduction in seizures) based on patient medical records or parental report.
• Patient and/or parent/caregiver able and willing to follow all study procedures and successfully complete the study.

You may not qualify if…

• Patients who have changed their KD regimen or antiseizure medication (ASM) or vagus nerve stimulation (VNS) within the last 28 days.
• Allergy, sensitivity to, or inability to metabolize any component of leucine enriched essential amino acid (LEAA).
• Those who are pregnant or breastfeeding.
• Patients who have received an investigational drug or product or participated in a drug study within 4 weeks before the first dose of leucine enriched essential amino acid (LEAA) powder.
• Patients who have a clinically significant condition or have had either clinically relevant symptoms or a clinically significant illness in the 4 weeks prior to the Baseline Visit 1, other than epilepsy, that would negatively impact study participation, collection of study data, or pose a risk to the patient including liver disease.
• Patients with history of suicidal ideation in past 6-months and suicidal behavior in past 2-years

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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