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NCT03924180: GLEEPHEN
Glytactin EfficiEncy in Non or Insufficiently Treated Adult PHENylketonuria Patients
NA trial testing Dietary Supplement for PKU patients in Adult Phenylketonuria Non Treated Patients in 13 participants. Completed in 5 September 2022.
14 March 2022
Quick facts
| Lead sponsor | University Hospital, Tours |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 13 |
| Start date | 19 September 2019 |
| Primary completion | 14 March 2022 |
| Estimated completion | 5 September 2022 |
| Sites | 7 locations across France |
Drugs / interventions tested
- Dietary Supplement for PKU patients
Conditions studied
- Adult Phenylketonuria Non Treated Patients — all drugs for Adult Phenylketonuria Non Treated Patients →
Sponsor
University Hospital, Tours
Who can join
18 and older, any sex, with Adult Phenylketonuria Non Treated Patients. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Phenylketonuria is the most common inherited metabolic disease in France and is screened for neonatal exposure. Management consists of a strict and restrictive hypoproteic diet and the intake of amino acid substitutes and dietary supplements free of phenylalanine.One of the major difficulties, which is the source of many treatment failures, is the inappetence of the amino acid supplements required during a strict hypoproteic diet. New formulations, Glycomacropeptides (GMP), have recently appeared and are considered more palatable than conventional amino acid mixtures.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03924180
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03924180 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University Hospital, Tours
- Last refreshed: 21 September 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03924180.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing