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COMPLETED
NCT06387186
PHASE1

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

Sponsor: Elizabeth Anne Thiele

View on ClinicalTrials.gov

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.

Official title: Open Label, Single-Arm Study of the Safety and Tolerability of a Leucine Enriched Essential Amino Acid Powder as an Add-on to a Classic Ketogenic Diet in Refractory Epilepsy

Key Details

Gender

All

Age Range

2 Years - Any

Study Type

INTERVENTIONAL

Enrollment

4

Start Date

2024-05-10

Completion Date

2026-02-18

Last Updated

2026-05-22

Healthy Volunteers

No

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.

Locations (1)

Massachusetts General Hospital

Boston, Massachusetts, United States