deltatrials
Completed PHASE2 INTERVENTIONAL 2-arm NCT03694275

A Multicenter, Open-label, Pilot Study of Soticlestat (TAK-935/OV935) in Participants With 15Q Duplication Syndrome (Dup 15q) or Cyclin-Dependent Kinase-Like 5 (CDKL5) Deficiency Disorder (ARCADE STUDY)

A Multicenter, Open-label, Pilot Study of TAK-935 (OV935) in Patients With 15Q Duplication Syndrome or CDKL5 Deficiency Disorder (ARCADE Study)

Sponsor: Healx AI

Interventions Soticlestat
Updated 17 times since 2018 Last updated: May 24, 2022 Started: Sep 10, 2018 Primary completion: Jul 13, 2020 Completion: Jul 31, 2020
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE2 trial investigates 15q Duplication Syndrome and CDKL5 Deficiency Disease and is currently completed. Healx AI leads this study, which shows 17 recorded versions since 2018 — indicating substantial longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

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 – ~Dec 2019 · 30 days · monthly snapshot~Dec 2019 – ~Feb 2020 · 2 months · monthly snapshot~Feb 2020 – ~Mar 2020 · 29 days · monthly snapshot~Mar 2020 – ~Jul 2020 · 4 months · monthly snapshot~Jul 2020 – ~Sep 2020 · 2 months · monthly snapshot~Sep 2020 – ~Jan 2021 · 4 months · monthly snapshot~Jan 2021 – ~May 2021 · 4 months · monthly snapshot~May 2021 – ~Jun 2022 · 13 months · monthly snapshot~Jun 2022 – ~Jul 2024 · 25 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Aug 2025 · 11 months · monthly snapshot~Aug 2025 – present · 13 months · monthly snapshot

Change History

17 versions recorded
  1. Aug 2025 — Present [monthly]

    Completed PHASE2

  2. Sep 2024 — Aug 2025 [monthly]

    Completed PHASE2

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE2

  4. Jun 2022 — Jul 2024 [monthly]

    Completed PHASE2

  5. May 2021 — Jun 2022 [monthly]

    Completed PHASE2

Show 12 earlier versions
  1. Jan 2021 — May 2021 [monthly]

    Completed PHASE2

  2. Sep 2020 — Jan 2021 [monthly]

    Completed PHASE2

    Status: Active Not RecruitingCompleted

  3. Jul 2020 — Sep 2020 [monthly]

    Active Not Recruiting PHASE2

    Status: RecruitingActive Not Recruiting

  4. Mar 2020 — Jul 2020 [monthly]

    Recruiting PHASE2

  5. Feb 2020 — Mar 2020 [monthly]

    Recruiting PHASE2

  6. Dec 2019 — Feb 2020 [monthly]

    Recruiting PHASE2

  7. Nov 2019 — Dec 2019 [monthly]

    Recruiting PHASE2

  8. May 2019 — Nov 2019 [monthly]

    Recruiting PHASE2

  9. Apr 2019 — May 2019 [monthly]

    Recruiting PHASE2

  10. Mar 2019 — Apr 2019 [monthly]

    Recruiting PHASE2

  11. Jan 2019 — Mar 2019 [monthly]

    Recruiting PHASE2

  12. Nov 2018 — Jan 2019 [monthly]

    Recruiting PHASE2

    First recorded

Sep 2018

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Healx AI
  • Takeda
Data source: Takeda

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