CompletedInterventionalPhase 3Last updated Nov 24, 2021

A Multicenter Study of the Efficacy and Safety of JZP-258 in the Treatment of Idiopathic Hypersomnia (IH) With an Open-label Safety Extension

A Double-blind, Placebo-controlled, Randomized Withdrawal, Multicenter Study of the Efficacy and Safety of JZP-258 in the Treatment of Idiopathic Hypersomnia (IH) With an Open-label Safety Extension

Overview

ClinicalTrials.gov ID: NCT03533114
Lead Sponsor: Jazz PharmaceuticalsINDUSTRY
Brief Summary: This is a study of the efficacy and safety of JZP-258, an oxybate mixed-salts oral solution being developed as a low sodium alternative product for Xyrem.
Study Type: Interventional

Status

Overall Status: Completed
Start Date: Nov 27, 2018Actual
Primary Completion Date: Jun 12, 2020Actual
Completion Date: Dec 18, 2020Actual

Study Record Dates

First Submitted: May 10, 2018
First Submitted that Met QC Criteria: May 10, 2018
First Posted: May 22, 2018Actual
Last Update Submitted that Met QC Criteria: Nov 18, 2021
Last Update Posted: Nov 24, 2021Actual
Last Verified: Nov 2021

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