# Safety and Therapeutic Effects of Sapropterin Dihydrochloride on Neuropsychiatric Symptoms in Phenylketonuria (PKU) Patients

> **NCT01114737** · PHASE3 · COMPLETED · sponsor: **BioMarin Pharmaceutical** · enrollment: 206 (actual)

## Conditions studied

- Phenylketonuria

## Interventions

- **DRUG:** Sapropterin dihydrochloride
- **DRUG:** Placebo

## Key facts

- **NCT ID:** NCT01114737
- **Lead sponsor:** BioMarin Pharmaceutical
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2010-08
- **Primary completion:** 2013-03
- **Final completion:** 2013-03
- **Target enrollment:** 206 (ACTUAL)
- **Last updated:** 2016-02-01


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT01114737

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT01114737, "Safety and Therapeutic Effects of Sapropterin Dihydrochloride on Neuropsychiatric Symptoms in Phenylketonuria (PKU) Patients". Retrieved via AI Analytics 2026-07-09 from https://api.ai-analytics.org/clinical/NCT01114737. Licensed CC0.

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