drugset / Trial / NCT03788343

Phenylalanine and Its Impact on Cognition

NCT03788343 ↗

RandomizedCrossoverDouble-blindSupportive care

Summary

The PICO-Study is a randomized, placebo-controlled, crossover, non-inferiority trial conducted to add evidence to the current European treatment guidelines for adult patients with phenylketonuria.

Timeline

Start
2019-08-19
Primary completion
2022-06-17
Completion
2022-06-17

Outcome

Met primary endpoint

paper For the primary endpoint, a 4-week increase of Phe intake was noninferior to placebo with respect to working memory accuracy PMID 38569786 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Phenylalanine Unknown 1500 mg Oral
Subject Phenylalanine Unknown 2000 mg Oral
Subject Phenylalanine Unknown 2500 mg Oral
Subject Phenylalanine Unknown 3000 mg Oral

Indications