deltatrials
Completed PHASE3 INTERVENTIONAL 3-arm NCT05156047

A Phase 3 Study to Assess the Safety and Efficacy of Pitolisant in Adult Patients With Idiopathic Hypersomnia

A Double-Blind, Placebo-Controlled, Randomized Withdrawal Study to Evaluate the Safety and Efficacy of Pitolisant in Adult Patients With Idiopathic Hypersomnia

Sponsor: Harmony Biosciences Management, Inc.

Conditions Idiopathic Hypersomnia
Interventions Double-blind pitolisant Double-blind placebo Open-label pitolisant
Updated 19 times since 2022 Last updated: Sep 9, 2024 Started: May 25, 2022 Primary completion: Sep 8, 2023 Completion: Sep 8, 2023
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE3 clinical study on Idiopathic Hypersomnia, this trial is completed. The trial is conducted by Harmony Biosciences Management, Inc. and has accumulated 19 data snapshots since 2022. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.

Status Flow

~Jan 2022 – ~Apr 2022 · 3 months · monthly snapshot~Apr 2022 – ~Jun 2022 · 2 months · monthly snapshot~Jun 2022 – ~Jul 2022 · 30 days · monthly snapshot~Jul 2022 – ~Sep 2022 · 2 months · monthly snapshot~Sep 2022 – ~Dec 2022 · 3 months · monthly snapshot~Dec 2022 – ~Jan 2023 · 31 days · monthly snapshot~Jan 2023 – ~Feb 2023 · 31 days · monthly snapshot~Feb 2023 – ~Mar 2023 · 28 days · monthly snapshot~Mar 2023 – ~Apr 2023 · 31 days · monthly snapshot~Apr 2023 – ~May 2023 · 30 days · monthly snapshot~May 2023 – ~Jun 2023 · 31 days · monthly snapshot~Jun 2023 – ~Oct 2023 · 4 months · monthly snapshot~Oct 2023 – ~Mar 2024 · 5 months · monthly snapshot~Mar 2024 – ~Jul 2024 · 4 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Oct 2024 · 30 days · monthly snapshot~Oct 2024 – ~Mar 2025 · 5 months · monthly snapshot~Mar 2025 – ~Sep 2025 · 6 months · monthly snapshot~Sep 2025 – present · 11 months · monthly snapshot

Change History

19 versions recorded

  1. Sep 2025 — Present [monthly]

    Completed PHASE3

  2. Mar 2025 — Sep 2025 [monthly]

    Completed PHASE3

  3. Oct 2024 — Mar 2025 [monthly]

    Completed PHASE3

  4. Sep 2024 — Oct 2024 [monthly]

    Completed PHASE3

  5. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE3

▶ Show 14 earlier versions

  1. Mar 2024 — Jul 2024 [monthly]

    Completed PHASE3

    Status: Active Not Recruiting → Completed

  2. Oct 2023 — Mar 2024 [monthly]

    Active Not Recruiting PHASE3

  3. Jun 2023 — Oct 2023 [monthly]

    Active Not Recruiting PHASE3

    Status: Recruiting → Active Not Recruiting

  4. May 2023 — Jun 2023 [monthly]

    Recruiting PHASE3

  5. Apr 2023 — May 2023 [monthly]

    Recruiting PHASE3

  6. Mar 2023 — Apr 2023 [monthly]

    Recruiting PHASE3

  7. Feb 2023 — Mar 2023 [monthly]

    Recruiting PHASE3

  8. Jan 2023 — Feb 2023 [monthly]

    Recruiting PHASE3

  9. Dec 2022 — Jan 2023 [monthly]

    Recruiting PHASE3

  10. Sep 2022 — Dec 2022 [monthly]

    Recruiting PHASE3

  11. Jul 2022 — Sep 2022 [monthly]

    Recruiting PHASE3

  12. Jun 2022 — Jul 2022 [monthly]

    Recruiting PHASE3

    Status: Not Yet Recruiting → Recruiting

  13. Apr 2022 — Jun 2022 [monthly]

    Not Yet Recruiting PHASE3

  14. Jan 2022 — Apr 2022 [monthly]

    Not Yet Recruiting PHASE3

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Harmony Biosciences Management, Inc.
Data source: Harmony Biosciences Management, Inc.

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

Study Locations

Ardmore, United States , Atlanta, United States , Austin, United States , Boston, United States , Boulder, United States , Brandon, United States , Canton, United States , Charleston, United States , Chattanooga, United States , Chesterfield, United States and 45 more locations