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

Launched by ELIZABETH ANNE THIELE · Apr 23, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a special powder called Leucine-Enriched Essential Amino Acid (LEAA) and how well it works when added to a classic ketogenic diet (KD) for people with refractory epilepsy. Refractory epilepsy means that the condition is hard to control with regular treatments, and participants in this study will have experienced at least two seizures a week. The main goal is to see if this new powder is safe and tolerable for patients aged 2 years and older who are already on a stable ketogenic diet and have seen some improvement in their seizures.

To be eligible for this trial, participants must have a diagnosis of epilepsy and be following a ketogenic diet with a specific ratio of fats to carbohydrates. They should also have a documented partial response to this diet, which means their seizures have reduced by at least 40% but not eliminated completely. However, patients who have changed their diet or medications recently, or have certain health issues, may not qualify. Throughout the study, participants can expect to follow specific procedures and provide feedback on their experience with the LEAA powder while continuing their diet. This study is not yet recruiting, so if you’re interested, keep an eye out for updates!

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Male or female patients ages 2 years and up at enrollment.
• • 2. 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.
• • 3. 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.
• • 4. Patient and/or parent/caregiver able and willing to follow all study procedures and successfully complete the study.
• Exclusion Criteria:
• • 1. Patients who have changed their KD regimen or antiseizure medication (ASM) or vagus nerve stimulation (VNS) within the last 28 days.
• • 2. Allergy, sensitivity to, or inability to metabolize any component of leucine enriched essential amino acid (LEAA).
• • 3. Those who are pregnant or breastfeeding.
• • 4. 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.
• • 5. 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.
• • 6. Patients with history of suicidal ideation in past 6-months and suicidal behavior in past 2-years