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Phase 3 Study to Evaluate the Efficacy & Safety of Self-Administered Injections of BMN165 by Adults With PKU

NCT01889862 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 215

Last updated 2021-05-21

Study results available
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Summary

The BMN 165 clinical development program has been designed to demonstrate the safety and efficacy of BMN 165 in reducing blood Phe concentrations in adults with PKU.

Conditions

  • Phenylketonuria (PKU)

Interventions

DRUG

BMN165 20mg/day

BMN165 20mg/day self-administered daily

DRUG

BMN165 40mg/day

BMN165 40mg/day self-administered daily

DRUG

Placebo

Non-drug placebo, self-administered daily

Sponsors & Collaborators

Principal Investigators

  • Clinical Trial Specialist · BioMarin Pharmaceutical

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-07-29
Primary Completion
2016-01-13
Completion
2019-02-05

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01889862 on ClinicalTrials.gov