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LNAA Supplement for Phenylketonuria

N/A

Waitlist Available

Led By Shoji Yano, MD, PhD

Research Sponsored by University of Southern California

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

demonstrates capacity to complete all requirements of the protocol

diagnosis of classical PKU (blood phenylalanine ≥1200 µmol pre-treatment or off-treatment)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 weeks

Awards & highlights

Study Summary

This trialinvestigates how adding a supplement to a restricted diet can improve symptoms of classical PKU in adults. 6 patients will be tested over 18-weeks with assessments done at home.

Who is the study for?

Adults over 18 with classical PKU, who have been on a phenylalanine restricted diet and have stable blood phenylalanine levels. They must be able to consent, follow the study protocol, not change their medication doses during the trial, and have regular access to phone and internet. Pregnant women or those planning pregnancy soon are excluded.Check my eligibility

What is being tested?

The trial is testing if adding LNAA supplements to the usual diet can improve symptoms in adults with PKU. It's an N-of-1 randomized controlled trial conducted at patients' homes over 18 weeks, followed by a 3-month period to check long-term benefits.See study design

What are the potential side effects?

Since this is about dietary supplementation rather than drug treatment, specific side effects aren't listed but could include potential digestive discomfort or allergic reactions related to LNAA intake.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can follow all the study's requirements.

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I have been diagnosed with classical PKU.

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I experience two or more symptoms from PKU that significantly affect my daily life.

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I follow a special diet and use medical foods for my PKU condition.

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I am 18 years old or older.

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I agree not to change my medication doses during the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Personalized Symptom Index

Secondary outcome measures

3-Day Diet Record

Absolute plasma phenylalanine concentration, dried blood spots (finger-prick method)

Adult ADHD Self-Report Scale (ASRS v1.1)

+5 more

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Active LNAAActive Control1 Intervention

Active LNAA tablets are given to each participant in 3 multiple crossovers for a total exposure to the Active Comparator 3 times. The allocation is randomized within each cycle of two treatments (active/inactive). There are 3 total cycles for each participant. The intervention is PreKUnil® tablets.

Group II: Inactive LNAAPlacebo Group1 Intervention

Inactive LNAA tablets (placebos) are given to each participant in 3 multiple crossovers for a total exposure to the Inactive Comparator 3 times. The allocation is randomized within each cycle of two treatments (inactive/active). There are 3 total cycles for each participant. The placebo intervention is PreKUnil® placebo tablets.

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Southern CaliforniaLead Sponsor

905 Previous Clinical Trials

1,596,308 Total Patients Enrolled

National PKU AllianceUNKNOWN

1 Previous Clinical Trials

9 Total Patients Enrolled

Shoji Yano, MD, PhDPrincipal InvestigatorKeck School of Medicine at USC

Media Library

Active LNAA Clinical Trial Eligibility Overview. Trial Name: NCT05174559 — N/A

Phenylketonuria Research Study Groups: Active LNAA, Inactive LNAA

Phenylketonuria Clinical Trial 2023: Active LNAA Highlights & Side Effects. Trial Name: NCT05174559 — N/A

Active LNAA 2023 Treatment Timeline for Medical Study. Trial Name: NCT05174559 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is recruitment still open for this clinical experiment?

"From the data on clinicaltrials.gov, it is clear that this trial has been recruiting since its inception on October 1st 2022 and continues to do so as of the most recent update from October 6th 2022."

Answered by AI

What particular objectives has this clinical trial set out to accomplish?

"This clinical trial will have a 3 week period for assessing the primary outcome, Personalized Symptom Index. Secondary assessments include Urine peripheral biomarkers of neurotransmitters (6-sulfatoxymelatonin and dopamine), Dietary LNAAs using 3-day diet records, and Absolute plasma phenylalanine concentration in dried blood spots obtained through finger-pricking."

Answered by AI

What is the current number of participants enrolled in this clinical experiment?

"Affirmative. According to clinicaltrials.gov, this investigation is currently sourcing for participants and was initially published on October 1st 2022 with the latest modification occurring 6 days later. The research necessitates 6 individuals at a single research facility."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Additional Dietary Large Neutral Amino Acids (LNAA) for Improved Symptoms in Adult Classical Phenylktonuria (PKU)

Shoji Yano 2023. "Additional Dietary Large Neutral Amino Acids (LNAA) for Improved Symptoms in Adult Classical Phenylktonuria (PKU)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05174559.

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