Stopped: Due to recruitment challenges, and despite an extension of the study period, the decision to terminate the trial early was made in agreement with the Principal Investigator
This is an open-label, randomized, 2-way crossover, monocentric controlled study in patients (≥ 16 years old) with phenylketonuria (PKU). The comparison will be between the test product (PKU GOLIKE, a prolonged-release amino-acids (AAs) mixture) and standard of care.
Age range
16 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Phe Blood Concentration With Dried Blood Spots (Umol/L) on the Second Test Day With Standard of Care Right Before Product Self-administration and Before Any Food Intake
Timeframe: at 8:00 am(±15 min) on the second test day (T2; T4) with SoC
Phe Blood Concentration With Dried Blood Spots (Umol/L) on the Second Test Day With GOLIKE PLUS Right Before Product Self-administration and Before Any Food Intake
Timeframe: at 8:00 am(±15 min) on the second test day (T2; T4) with Golike Plus
Phe Blood Concentration With Dried Blood Spots (Umol/L) on the Second Test Day With Standard of Care Right Before Product Self-administration and Before Food Intake
Timeframe: at 12:00 am (±15 min) on the second test day (T2; T4)with SoC
Phe Blood Concentration With Dried Blood Spots (Umol/L) on the Second Test Day With GOLIKE PLUS Right Before Product Self-administration and Before Food Intake
Timeframe: at 12:00 am (±15 min) on the second test day (T2; T4) with Golike Plus
Phe Blood Concentration With Dried Blood Spots (Umol/L) on the Second Test Day With Standard of Care Before Food Intake
Timeframe: At 4:00 pm (±15 min) on the second test (T2;T4) day with SoC
Phe Blood Concentration With Dried Blood Spots (Umol/L) on the Second Test Day With GOLIKE PLUS Before Food Intake
Timeframe: At 4:00 pm (±15 min) on the second test day (T2; T4) with Golike Plus
Phe Blood Concentration With Dried Blood Spots (Umol/L) on the Second Test Day With Standard of Care Right Before Product Self-administration and Before Any Food Intake
Timeframe: at 8:00 pm (±15 min) on the second test day (T2; T4) with SoC
Phe Blood Concentration With Dried Blood Spots (Umol/L) on the Second Test Day With GOLIKE PLUS Right Before Product Self-administration and Before Any Food Intake
Timeframe: at 8:00 pm (±15 min) on the second test day (T2; T4) with Golike Plus
Phe Blood Concentration With Dried Blood Spots (Umol/L) on the Day Following the Second Test Day With Standard of Care on the Following Morning, Before Any Food Intake.
Timeframe: at 8:00 am (±15 min) on the day following the second test day (T2; T4) with SoC
Phe Blood Concentration With Dried Blood Spots (Umol/L) on the Day Following the Second Test Day With GOLIKE PLUS on the Following Morning, Before Any Food Intake.
Timeframe: at 8:00 am (±15 min) on the day following the second test day (T2; T4) with Golike Plus