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A Multicenter Study of the Efficacy and Safety of Xyrem With an Open- Label Pharmacokinetic Evaluation and Safety Extension in Pediatric Subjects With Narcolepsy With Cataplexy

NCT02221869 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 106

Last updated 2019-04-30

Study results available
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Summary

The purpose of this trial is to assess the efficacy and safety of Xyrem in pediatrics subjects with narcolepsy that includes cataplexy.

Conditions

  • Narcolepsy With Cataplexy

Interventions

DRUG

Xyrem

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
7 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-01
Primary Completion
2017-02-28
Completion
2019-01-25

Countries

  • United States
  • France
  • Italy
  • Netherlands

Study Locations

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Entities

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 NCT02221869 on ClinicalTrials.gov