15 Participants Needed

Amino Acid Supplement for Epilepsy

LT
CW
Overseen ByCarolyn Wilson
Age: Any Age
Sex: Any
Trial Phase: Phase 1
Sponsor: Elizabeth Anne Thiele
Must be taking: Ketogenic diet
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

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.

Who Is on the Research Team?

ET

Elizabeth Thiele, MD,PhD

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

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.
See 1 more

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
See 3 more

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Leucine-Enriched Essential Amino Acid powder (LEAA)Experimental Treatment1 Intervention
Leucine-Enriched Essential Amino Acid powder (LEAA) as an add-on to a classic ketogenic diet (KD)

Find a Clinic Near You

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+
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