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Clinical trials for Phenylalanine

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
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    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
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    The EU Clinical Trials Register currently displays   44334   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
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    53 result(s) found for: Phenylalanine. Displaying page 1 of 3.
    1  2  3  Next»
    EudraCT Number: 2010-021343-41 Sponsor Protocol Number: ME040 Start Date*: 2014-03-21
    Sponsor Name:University Medical Center Groningen
    Full Title: Effect of sapropterin on variations of blood phenylalanine and tyrosine over 24 hours and from day to day in children with phenylketonuria
    Medical condition: Phenylketonuria (PKU) is an autosomal recessive metabolic genetic disorder by a mutation in the gene for the enzyme phenylalanine hydroxylase (PAH), rendering it nonfunctional. Left untreated, the ...
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2006-000648-15 Sponsor Protocol Number: BH4/III/05/001 Start Date*: 2006-06-08
    Sponsor Name:ORPHANETICS Pharma Entwicklungs- GmbH
    Full Title: A double-blind, placebo-controlled, multicentre study with an open-label extension to evaluate the efficacy and safety of tetrahydrobiopterin (BH4) in children and adolescents with hyperphenylalani...
    Medical condition: Hyperphenylalaninemia due to phenylalanine hydroxylase deficiency. Phenotypes: classic phenylketonuria (PKU), mild PKU (MPK) or mild hyperphenylalaninemia (HPA).
    Disease: Version SOC Term Classification Code Term Level
    81 10034873 LLT
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: AT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2015-001650-15 Sponsor Protocol Number: EMR700773-510 Start Date*: 2015-06-26
    Sponsor Name:Merck Serono Middle East FZ-LLC
    Full Title: A Phase III Non-comparative Open-label Clinical Study to Evaluate the Response to and Safety of Kuvan (Sapropterin Dihydrochloride) After 6 Weeks of Treatment in Patients of 4 to 18 Years of Age Wi...
    Medical condition: Phenylketonuria
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2021-003777-63 Sponsor Protocol Number: 202100482 Start Date*: Information not available in EudraCT
    Sponsor Name:University Medical Center Groningen
    Full Title: Tetrahydrobiopterin (BH4) treatment in Phenylketonuria - comparing different practices of dosing regimen
    Medical condition: Phenylketonuria (PKU; OMIM 261600)
    Disease:
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2004-002365-21 Sponsor Protocol Number: BH4-1 Start Date*: 2004-11-03
    Sponsor Name:John F. Kennedy Institute
    Full Title: Trial with BH4, a new and simple treatment of phenylketonuria, PKU
    Medical condition: PKU, phenylketonuria, is a rare, inherited metabolic disease that results in mental retardation if not a very strict low-protein diet is started within the first weeks of life. The conversion of p...
    Disease:
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: DK (Completed)
    Trial results: (No results available)
    EudraCT Number: 2004-004513-41 Sponsor Protocol Number: PKU-004 Start Date*: 2005-10-25
    Sponsor Name:BioMarin Pharmaceutical Inc.
    Full Title: A Phase 3, Multicenter, Open-Label Extension Study of Phenoptin in Subjects with Phenylketonuria Who Have Elevated Phenylalanine Levels
    Medical condition: Phenylketonuria (PKU)
    Disease: Version SOC Term Classification Code Term Level
    6.1 10034872
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) IE (Completed) IT (Completed) DE (Completed)
    Trial results: View results
    EudraCT Number: 2021-002329-56 Sponsor Protocol Number: FISIO Start Date*: 2021-10-19
    Sponsor Name:Sociedad Española de Medicina Intensiva, Crítica y Unidades Coronarias (SEMICYUC)
    Full Title: Exploratory study to evaluate the efficacy and safety of nutritionally administering 1.5 g protein/kg/day vs. 1.0 g protein/kg/day in the catabolic phase of the critically ill patient on mechanical...
    Medical condition: Acquired Weakness in the Intensive Care Unit (DAUCI) of the critically ill patient.
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029205 - Nervous system disorders 10077255 Intensive care unit acquired weakness PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2009-012602-39 Sponsor Protocol Number: 05-NEOV-002 Start Date*: 2010-05-17
    Sponsor Name:Fresenius Kabi Deutschland GmbH
    Full Title: A randomised, double-blind study evaluating the safety, tolerability, protein accretion, amino acid plasma levels and long-term outcome of Neoven compared to Vaminolact(R) in premature very low bir...
    Medical condition: The product is aimed to be used where parenteral nutrition is required. The intended indication is: Supply of essential and non-essential amino acids as part of parenteral nutrition for premature ...
    Disease: Version SOC Term Classification Code Term Level
    12.1 10051284 Parenteral nutrition LLT
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: DE (Prematurely Ended) NL (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2004-002071-16 Sponsor Protocol Number: PKU-001 Start Date*: Information not available in EudraCT
    Sponsor Name:BioMarin Pharmaceutical Inc.
    Full Title: A Phase 2, Multicenter, Open-Label Study to Evaluate the Response to and Safety of an 8-Day Course of Phenoptin Treatment in Subjects with Phenylketonuria Who Have Elevated Phenylalanine Levels
    Medical condition: Phenylketonuria (PKU)
    Disease: Version SOC Term Classification Code Term Level
    6.1 10034872
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: IE (Completed) DE (Completed) GB (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2005-003777-24 Sponsor Protocol Number: PKU-006 Start Date*: 2006-03-24
    Sponsor Name:BioMarin Pharmaceutical Inc.
    Full Title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of Phenoptin 20 mg/kg/day to Increase Phenylalanine Tolerance in Phenylketonuric Child...
    Medical condition: Phenylketonuria (PKU)
    Disease: Version SOC Term Classification Code Term Level
    6.1 10034872
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed) ES (Completed) GB (Completed)
    Trial results: (No results available)
    EudraCT Number: 2010-019767-11 Sponsor Protocol Number: Ö-PKU1 Start Date*: 2010-09-08
    Sponsor Name:Graz Medical University
    Full Title: Ö-PKU 1 – Evaluation of a Test for the identication of BH4 responsive PKU patients
    Medical condition: Hyperphenylalaninaemia (HPA) in adult and paediatric patients of 4 years of age and over with phenylketonuria (PKU).
    Disease:
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: AT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2009-018168-81 Sponsor Protocol Number: EMR-700773-503 Start Date*: 2010-04-16
    Sponsor Name:Merck Serono Norway
    Full Title: ENDURE: A Phase IV, prospective, open-label, uncontrolled, multi-centre cohort trial to assess the responsiveness of subjects with phenylketonuria (PKU) to treatment with Kuvan® 20 mg/kg/day for 28...
    Medical condition: Subjects diagnosed with Phenylketonuria (PKU) (classic or mild PKU, or mild hyperphenylalaninaemia (HPA)).
    Disease: Version SOC Term Classification Code Term Level
    14.1 10010331 - Congenital, familial and genetic disorders 10034873 Phenylketonuria (PKU) LLT
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Completed) NO (Ongoing)
    Trial results: View results
    EudraCT Number: 2009-012604-92 Sponsor Protocol Number: 05-NEOV-004 Start Date*: 2010-04-19
    Sponsor Name:Fresenius Kabi Deutschland GmbH
    Full Title: A randomised, double-blind study of the safety and efficacy of Neoven compared to Vaminolact in infants and children requiring long-term parenteral nutrition
    Medical condition: The product is aimed to be used where parenteral nutrition is required. The intended indication is: Supply of essential and non-essential amino acids as part of Parenteral Nutrition for infants an...
    Disease: Version SOC Term Classification Code Term Level
    12.1 10051284 Parenteral nutrition LLT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: FR (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2008-000429-20 Sponsor Protocol Number: 05-NEOV-001 Start Date*: 2008-10-17
    Sponsor Name:Fresenius Kabi Deutschland GmbH
    Full Title: A randomised, double-blind study evaluating the safety, tolerability, and amino acid plasma levels of Neoven compared to Vaminolact in infants after surgical interventions.
    Medical condition: The product is aimed to be used where parenteral nutrition is required. The indended indication is: Supply of essential and non-essential amino acids as part of parenteral nutrition for preterm an...
    Disease: Version SOC Term Classification Code Term Level
    9.1 10051284 Parenteral nutrition LLT
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: NL (Completed) BE (Completed) DE (Completed)
    Trial results: View results
    EudraCT Number: 2009-015844-41 Sponsor Protocol Number: BMN162-502 Start Date*: 2013-07-25
    Sponsor Name:BioMarin International Ltd.
    Full Title: A Phase IV Open-Label, Single-Cohort Study of the Long-Term Neurocognitive Outcomes in 4 to 5 Year-Old Children with Phenylketonuria Treated with Sapropterin Dihydrochloride (Kuvan®) for 7 Years.
    Medical condition: Phenylketonuria
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004850 10034873 Phenylketonuria (PKU) LLT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed) DE (Completed) IT (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2004-004512-23 Sponsor Protocol Number: PKU-003 Start Date*: 2005-05-22
    Sponsor Name:BioMarin Pharmaceutical Inc.
    Full Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Phenoptin in Subjects with Phenylketonuria Who Have Elevated Phenylalanine Levels
    Medical condition: Phenylketonuria (PKU)
    Disease: Version SOC Term Classification Code Term Level
    6.1 10034872
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: IE (Completed) GB (Completed) DE (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2009-015768-33 Sponsor Protocol Number: EMR700773-003/BMN162-503 Start Date*: 2011-01-04
    Sponsor Name:BioMarin International Ltd.
    Full Title: A Phase IIIb, Multicentre, Open-Label, Randomized, Controlled Study of the Efficacy, Safety, and Population Pharmacokinetics of Sapropterin Dihydrochloride (Kuvan®) in Phenylketonuria (PKU) Patient...
    Medical condition: Phenylketonuria
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004850 10034873 Phenylketonuria (PKU) LLT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed) SK (Completed) DE (Completed) AT (Completed) CZ (Completed) PT (Completed) BE (Completed) NL (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2009-012603-26 Sponsor Protocol Number: 05-NEOV-003 Start Date*: 2010-04-08
    Sponsor Name:Fresenius Kabi Deutschland GmbH [...]
    1. Fresenius Kabi Deutschland GmbH
    2. Fresenius Kabi Deutschland GmbH
    Full Title: A randomised, double-blind study evaluating the safety, tolerability and clinical outcome of Neoven compared to Vaminolact in premature ELBW infants
    Medical condition: The product is aimed to be used where parenteral nutrition is required. The intended indication is: Supply of essential and non-essential amino acids as part of Parenteral Nutrition for premature ...
    Disease: Version SOC Term Classification Code Term Level
    12.1 10051284 Parenteral nutrition LLT
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: BE (Completed) DE (Prematurely Ended) FR (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2021-000474-29 Sponsor Protocol Number: PTC923-MD-003-PKU Start Date*: Information not available in EudraCT
    Sponsor Name:PTC Therapeutics, Inc.
    Full Title: A Phase 3 Study of PTC923 in Subjects with Phenylketonuria
    Medical condition: Metabolic Disorders - Phenylketonuria
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10034873 Phenylketonuria (PKU) LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) ES (Ongoing) PT (Completed) DK (Completed) NL (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2021-000497-28 Sponsor Protocol Number: PTC923-MD-004-PKU Start Date*: Information not available in EudraCT
    Sponsor Name:PTC Therapeutics, Inc.
    Full Title: Phase 3 Open-Label Study of PTC923 (Sepiapterin) in Phenylketonuria
    Medical condition: Metabolic Disorders - Phenylketonuria
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10034873 Phenylketonuria (PKU) LLT
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Trial now transitioned) ES (Ongoing) PT (Trial now transitioned) DK (Trial now transitioned) NL (Trial now transitioned) IT (Trial now transitioned)
    Trial results: (No results available)
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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