NCT00937794

Screening Study to Identify Pediatric Patients With Hunter Syndrome Who Demonstrate Evidence of Central Nervous System (CNS) Involvement and Who Are Currently Receiving Treatment With Elaprase®

A Screening Study to Identify Pediatric Patients With Hunter Syndrome Who Demonstrate Evidence of Central Nervous System Involvement and Who Are Currently Receiving Treatment With Elaprase®

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 33 (actual)
• Sponsor: Shire · Industry
• Sex: Male
• Age: 32 Months – 18 Years
• Healthy volunteers: Not accepted

Summary

This study is being conducted to identify pediatric patients with Hunter syndrome who have neurodevelopmental disease characteristics, who are currently receiving treatment with Elaprase, and who may be suitable to participate in a clinical study with an investigational agent.

Conditions

• Hunter Syndrome

Interventions

Type	Name	Description
BEHAVIORAL	Neurobehavioral testing	If the patient is found to be eligible after completion of a telephone interview, he will undergo further testing to assess his neurodevelopmental status using a standardized battery of neurobehavioral testing.
OTHER	Visual and auditory assessments	If the patient is found to be eligible after completion of a telephone interview, he will undergo further testing to evaluate his visual and auditory function.

Timeline

• Start date: 2009-07-02
• Primary completion: 2011-07-13
• Completion: 2011-07-13
• First posted: 2009-07-13
• Last updated: 2021-06-14
• Results posted: 2016-05-16

Locations

2 sites across 2 countries: United States, United Kingdom