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Could a simple amino acid boost seizure control in tough epilepsy?

NCT ID NCT06387186

Symptom relief Sponsor: Elizabeth Anne Thiele Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This small study tested a leucine-enriched amino acid powder given alongside a classic ketogenic diet in 4 people with drug-resistant epilepsy. The main goal was to see if the powder is safe and tolerable. Researchers also checked if it helped with nutrition. Because it was a very early, single-arm trial with no placebo group, it can only hint at possible benefits.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Leucine-enriched essential amino acid powder
What this could lead to
If it works, this could point toward a safe way to improve seizure control and nutrition for people with drug-resistant epilepsy who are already on a ketogenic diet.
What could go wrong
This is a very early, tiny study with only 4 participants and no comparison group. It only looks at safety, not whether seizures actually improve. Results may not apply to others.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

4 people

The number who actually took part.

Started

May 2024

Finished

Feb 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

2 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Drug Resistant Epilepsy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Drug resistant epilepsy Refractory epilepsy

Contacts and locations

Locations

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.