deltatrials
Completed PHASE3 NCT00066170

Trial Comparing Effects of Xyrem Taken Orally and Modafinil With Placebo in Treating Daytime Sleepiness in Narcolepsy

Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Parallel-Group, Multi-Center Trial Comparing the Effects of Orally Administered Xyrem (Sodium Oxybate) and Modafinil With Placebo in Treatment of Daytime Sleepiness in Narcolepsy

Sponsor: Jazz Pharmaceuticals

Conditions Narcolepsy
Interventions Modafinil (Placebo) Modafinil at established dose Xyrem Xyrem Placebo
Updated 6 times since 2017 Last updated: Dec 21, 2011 Started: Apr 30, 2003 Primary completion: Jul 31, 2004 Completion: Nov 30, 2004

Listed as NCT00066170, this PHASE3 trial focuses on Narcolepsy and remains completed. Sponsored by Jazz Pharmaceuticals, it has been updated 6 times since 2003, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Change History

6 versions recorded

  1. Sep 2024 — Present [monthly]

    Completed PHASE3

  2. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE3

  3. Jan 2021 — Jul 2024 [monthly]

    Completed PHASE3

  4. Jun 2018 — Jan 2021 [monthly]

    Completed PHASE3

  5. Feb 2017 — Jun 2018 [monthly]

    Completed PHASE3

▶ Show 1 earlier version

  1. Jan 2017 — Feb 2017 [monthly]

    Completed PHASE3

    First recorded

Apr 2003

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Jazz Pharmaceuticals
Data source: Jazz Pharmaceuticals

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Allentown, United States, Bowling Green, United States, Carlisle, United States, Charleston, United States, Chevy Chase, United States, Cincinnati, United States, Columbia, United States, Crestview Hills, United States, Danville, United States, Detroit, United States and 26 more location s