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Amino Acid Supplement for Epilepsy

Phase 1
Waitlist Available
Led By Elizabeth Thiele, MD, PhD
Research Sponsored by Elizabeth Anne Thiele
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Under stable treatment with a classic ketogenic diet (KD) regimen with a KD ratio ≥ 1:1 for at least 28 days with documented partial response
Diagnosis of epilepsy with at least 2 seizures per week
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 3 weeks, 12 weeks
Awards & highlights
No Placebo-Only Group

Summary

"This trial aims to test if adding a Leucine-Enriched Essential Amino Acid Powder to a classic ketogenic diet is safe and well-tolerated in children and adults with epilepsy that does

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While specific side effects aren't listed here, participants will be monitored for any adverse reactions due to the LEAA powder addition. This could include digestive issues, potential allergies or intolerances related specifically to leucine or other amino acids.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I've been on a ketogenic diet with a ratio of at least 1:1 for over 28 days and have seen some improvement.
Select...
I have epilepsy with 2 or more seizures weekly.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 3 weeks, 12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 3 weeks, 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of participants with treatment-related adverse events
Secondary study objectives
Number of participants with improved nutritional status as assessed by body mass index (BMI).
Number of participants with improved nutritional status as assessed by serum ketone and glucose level.
Number of participants with improved nutritional status as assessed by weight.
Other study objectives
Changes in behavior and cognitive function as assessed by a questionnaire.
Changes in seizure frequency as assessed by seizure diary.
Changes in seizure severity and overall health as assessed by a questionnaire.

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

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)

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Who is running the clinical trial?

Elizabeth Anne ThieleLead Sponsor
1 Previous Clinical Trials
20 Total Patients Enrolled
1 Trials studying Epilepsy
20 Patients Enrolled for Epilepsy
Ajinomoto USA, INC.Industry Sponsor
10 Previous Clinical Trials
1,588 Total Patients Enrolled
Ajinomoto Co., Inc.Industry Sponsor
19 Previous Clinical Trials
1,102 Total Patients Enrolled
~5 spots leftby Mar 2025
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