Amino Acid Supplement for Epilepsy

Overseen By Carolyn Wilson

Age: Any Age

Sex: Any

Trial Phase: Phase 1

Sponsor: Elizabeth Anne Thiele

Must be taking: Ketogenic diet

Disqualifiers: Pregnancy, Liver disease, Suicidal history, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 12 weeks

15 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Elizabeth Thiele, MD,PhD

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

This trial is for pediatric and adult patients with epilepsy who experience at least 2 seizures per week, are on a stable classic ketogenic diet (KD) with partial response, and can follow study procedures. It's not for those allergic to LEAA components, recently ill in a way that affects participation, pregnant or breastfeeding individuals, anyone on recent investigational drugs, or those who've changed their KD regimen or seizure medication lately.

Inclusion Criteria

I have epilepsy with 2 or more seizures weekly.

Patient and/or parent/caregiver able and willing to follow all study procedures

I've been on a ketogenic diet with a ratio of at least 1:1 for over 28 days and have seen some improvement.

Exclusion Criteria

Allergy, sensitivity to, or inability to metabolize any component of leucine enriched essential amino acid (LEAA)

Clinically significant condition or illness in the 4 weeks prior to Baseline Visit 1 that would negatively impact study participation

Pregnant or breastfeeding patients

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-screening communication via telephone/video

Treatment

Participants receive Leucine-Enriched Essential Amino Acid powder as an add-on to a classic ketogenic diet

12 weeks

3 remote visits (Baseline, Dose Adjustment, Final)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Leucine-Enriched Essential Amino Acid Powder

Trial Overview The trial tests the safety of adding Leucine-Enriched Essential Amino Acid (LEAA) Powder to a classic ketogenic diet in patients with refractory epilepsy. The goal is to see if this add-on helps manage seizures better than the diet alone.

Participant Groups

Group I: Leucine-Enriched Essential Amino Acid powder (LEAA) Experimental Treatment 1 Intervention

Leucine-Enriched Essential Amino Acid powder (LEAA) as an add-on to a classic ketogenic diet (KD)

Who Is Running the Clinical Trial?

Elizabeth Anne Thiele

Lead Sponsor

Trials

2

Recruited

40+

Ajinomoto USA, INC.

Industry Sponsor

Trials

11

Recruited

1,600+

Ajinomoto Co., Inc.

Industry Sponsor

Trials

21

Recruited

1,200+