deltatrials
Completed PHASE3 NCT03714373

Open-Label Extension Study of DCCR in PWS Followed by Double-Blind, Placebo-Controlled, Randomized Withdrawal Period

An Open-Label, Long-Term Safety and Efficacy Evaluation of Diazoxide Choline Extended-Release Tablets in Participants With Prader-Willi Syndrome With a Double-Blind, Placebo-Controlled, Randomized Withdrawal Period

Sponsor: Soleno Therapeutics, Inc.

Updated 16 times since 2018 Last updated: Apr 18, 2024 Started: Oct 1, 2018 Primary completion: Aug 17, 2023 Completion: Aug 17, 2023

A PHASE3 clinical study on Prader-Willi Syndrome, this trial is completed. The trial is conducted by Soleno Therapeutics, Inc. and has accumulated 16 data snapshots since 2018. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.

Status Flow

~Nov 2018 – ~Jan 2019 · 2 months · monthly snapshot~Jan 2019 – ~Mar 2019 · 59 days · monthly snapshot~Mar 2019 – ~Apr 2019 · 31 days · monthly snapshot~Apr 2019 – ~May 2019 · 30 days · monthly snapshot~May 2019 – ~Nov 2019 · 6 months · monthly snapshot~Nov 2019 – ~Jan 2020 · 2 months · monthly snapshot~Jan 2020 – ~Feb 2020 · 31 days · monthly snapshot~Feb 2020 – ~Jul 2020 · 5 months · monthly snapshot~Jul 2020 – ~Jan 2021 · 6 months · monthly snapshot~Jan 2021 – ~Jul 2022 · 18 months · monthly snapshot~Jul 2022 – ~Dec 2022 · 5 months · monthly snapshot~Dec 2022 – ~Jul 2023 · 7 months · monthly snapshot~Jul 2023 – ~May 2024 · 10 months · monthly snapshot~May 2024 – ~Jul 2024 · 2 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – present · 19 months · monthly snapshot

Change History

16 versions recorded
  1. Sep 2024 — Present [monthly]

    Completed PHASE3

  2. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE3

  3. May 2024 — Jul 2024 [monthly]

    Completed PHASE3

    Status: Active Not RecruitingCompleted

  4. Jul 2023 — May 2024 [monthly]

    Active Not Recruiting PHASE3

  5. Dec 2022 — Jul 2023 [monthly]

    Active Not Recruiting PHASE3

Show 11 earlier versions
  1. Jul 2022 — Dec 2022 [monthly]

    Active Not Recruiting PHASE3

  2. Jan 2021 — Jul 2022 [monthly]

    Active Not Recruiting PHASE3

  3. Jul 2020 — Jan 2021 [monthly]

    Active Not Recruiting PHASE3

    Status: RecruitingActive Not Recruiting

  4. Feb 2020 — Jul 2020 [monthly]

    Recruiting PHASE3

  5. Jan 2020 — Feb 2020 [monthly]

    Recruiting PHASE3

  6. Nov 2019 — Jan 2020 [monthly]

    Recruiting PHASE3

  7. May 2019 — Nov 2019 [monthly]

    Recruiting PHASE3

  8. Apr 2019 — May 2019 [monthly]

    Recruiting PHASE3

  9. Mar 2019 — Apr 2019 [monthly]

    Recruiting PHASE3

  10. Jan 2019 — Mar 2019 [monthly]

    Recruiting PHASE3

  11. Nov 2018 — Jan 2019 [monthly]

    Recruiting PHASE3

    First recorded

Oct 2018

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Soleno Therapeutics, Inc.
Data source: Soleno Therapeutics, Inc.

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