deltatrials
Completed PHASE2 INTERVENTIONAL 1-arm NCT03493607

AMO-01 to Treat Adolescents and Adults With Phelan-McDermid Syndrome (PMS) and Co-morbid Epilepsy

An Open-label Study to Investigate the Safety, Tolerability and Efficacy of a Single 6-hour Intravenous Infusion of AMO-01 to Treat Adolescents and Adults With Phelan-McDermid Syndrome (PMS) and Co-morbid Epilepsy

Sponsor: Alexander Kolevzon

Conditions Epilepsy Phelan-McDermid Syndrome
Interventions AMO-01
Updated 15 times since 2018 Last updated: Jun 13, 2025 Started: May 30, 2018 Primary completion: Mar 31, 2020 Completion: Mar 31, 2020
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT03493607, this PHASE2 trial focuses on Epilepsy and Phelan-McDermid Syndrome and remains completed. Sponsored by Alexander Kolevzon, it has been updated 15 times since 2018, reflecting substantial change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Status Flow

~May 2018 – ~Jun 2018 · 31 days · monthly snapshot~Jun 2018 – ~Aug 2018 · 2 months · monthly snapshot~Aug 2018 – ~May 2019 · 9 months · monthly snapshot~May 2019 – ~Jul 2019 · 2 months · monthly snapshot~Jul 2019 – ~Feb 2020 · 7 months · monthly snapshot~Feb 2020 – ~Aug 2020 · 6 months · monthly snapshot~Aug 2020 – ~Jan 2021 · 5 months · monthly snapshot~Jan 2021 – ~Apr 2021 · 3 months · monthly snapshot~Apr 2021 – ~Sep 2021 · 5 months · monthly snapshot~Sep 2021 – ~Dec 2022 · 15 months · monthly snapshot~Dec 2022 – ~Jan 2023 · 31 days · monthly snapshot~Jan 2023 – ~Jul 2024 · 18 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Jul 2025 · 10 months · monthly snapshot~Jul 2025 – present · 14 months · monthly snapshot

Change History

15 versions recorded

  1. Jul 2025 — Present [monthly]

    Completed PHASE2

  2. Sep 2024 — Jul 2025 [monthly]

    Completed PHASE2

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE2

  4. Jan 2023 — Jul 2024 [monthly]

    Completed PHASE2

  5. Dec 2022 — Jan 2023 [monthly]

    Completed PHASE2

▶ Show 10 earlier versions

  1. Sep 2021 — Dec 2022 [monthly]

    Completed PHASE2

  2. Apr 2021 — Sep 2021 [monthly]

    Completed PHASE2

    Status: Recruiting → Completed

  3. Jan 2021 — Apr 2021 [monthly]

    Recruiting PHASE2

  4. Aug 2020 — Jan 2021 [monthly]

    Recruiting PHASE2

  5. Feb 2020 — Aug 2020 [monthly]

    Recruiting PHASE2

  6. Jul 2019 — Feb 2020 [monthly]

    Recruiting PHASE2

  7. May 2019 — Jul 2019 [monthly]

    Recruiting PHASE2

  8. Aug 2018 — May 2019 [monthly]

    Recruiting PHASE2

  9. Jun 2018 — Aug 2018 [monthly]

    Recruiting PHASE2

  10. May 2018 — Jun 2018 [monthly]

    Recruiting PHASE2

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Alexander Kolevzon
Data source: Icahn School of Medicine at Mount Sinai

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

Study Locations