Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT01114737 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Phenylketonuria, sponsored by BioMarin Pharmaceutical.

Completed
Registry status
Phase 3
Development phase
206
Enrollment target
20
Study locations

NCT01114737 is a Phase 3 study of Phenylketonuria that has completed, run by BioMarin Pharmaceutical. The registered enrollment target is 206 participants, above the 82-participant average among 12 other Phenylketonuria trials with a reported enrollment target (151% higher). The trial reports 20 study locations across 14 states.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT01114737, a Phase 3 study of Phenylketonuria, has completed, sponsored by BioMarin Pharmaceutical.

COMPLETED
Registry status
Phase 3
Development phase
206 participants
Enrollment target
20
Study locations

Study Summary

This double-blind, placebo-controlled, randomized study is designed to evaluate the safety and therapeutic effects of sapropterin dihydrochloride on neuropsychiatric symptoms in subjects with PKU.

Conditions Studied

Phenylketonuria

Interventions

  • DRUG Placebo
  • DRUG Sapropterin dihydrochloride

Study Locations (20)

California

  • - La Jolla
  • - Los Angeles
  • - Palo Alto
  • - San Francisco

New York

  • - Albany
  • - Buffalo
  • - Rochester

Florida

  • - Gainesville
  • - Tampa

Colorado

  • - Aurora

District of Columbia

  • - Washington D.C.

Georgia

  • - Atlanta

Illinois

  • - Chicago

Indiana

  • - Indianapolis

Trial Details

FieldValue
Enrollment Target 206 participants
Start Date 2010-08
Est. Completion 2013-03
Phase Phase 3

Sponsor

BioMarin Pharmaceutical

80 total trials

Interested in This Trial?

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01114737

The ClinicalTrials.gov registry entry for NCT01114737 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 206 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 82-participant average among 12 other Phenylketonuria trials with a reported enrollment target (151% higher). The listed sponsor is BioMarin Pharmaceutical, which has 80 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Phenylketonuria appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT01114737 reports 20 study locations spanning 14 distinct geographic areas - top geographies include California, New York, Florida.

Frequently Asked Questions

What is clinical trial NCT01114737 about?

NCT01114737 is a clinical study titled "Safety and Therapeutic Effects of Sapropterin Dihydrochloride on Neuropsychiatric Symptoms in Phenylketonuria (PKU) Patients". This double-blind, placebo-controlled, randomized study is designed to evaluate the safety and therapeutic effects of sapropterin dihydrochloride on neuropsychiatric symptoms in subjects with PKU.

What is the current status of trial NCT01114737?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 206 participants. The study started on 2010-08. Estimated completion is 2013-03.

What conditions does trial NCT01114737 study?

This clinical trial studies the following conditions: Phenylketonuria.

What interventions are being tested in trial NCT01114737?

The interventions under investigation include: Placebo (DRUG), Sapropterin dihydrochloride (DRUG).

Who is sponsoring clinical trial NCT01114737?

This trial is sponsored by BioMarin Pharmaceutical, which has 80 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01114737 being conducted?

This trial has 20 study locations across California, Colorado, District of Columbia, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Phenylketonuria

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Explore more on PlainTrial

Phenylketonuria

All registered trials for this condition

California

All trials with a study site in California

Recruiting now

Find trials open to new participants near you

Rankings

Top sponsors, conditions, and phases

Read our methodology - how this data is sourced, computed, and verified.

Related

Browse all → | Rankings →
Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.