deltatrials
Terminated PHASE3 INTERVENTIONAL 3-arm NCT02945046

A Study to Evaluate the Efficacy and Safety of TEV-48125 (Fremanezumab) for the Prevention of Episodic Cluster Headache (ECH)

A Multicenter, Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Parallel-Group Study Comparing the Efficacy and Safety of 2 Dose Regimens (Intravenous/Subcutaneous and Subcutaneous) of TEV-48125 Versus Placebo for the Prevention of Epidosic Cluster Headache

Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.

Updated 28 times since 2017 Last updated: Nov 6, 2021 Started: Jan 19, 2017 Primary completion: May 13, 2019 Completion: May 13, 2019
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Terminated

Study was terminated as a result of a pre-specified futility analysis at the interim of 150 participants completing the efficacy analysis of the study.

This PHASE3 trial investigates Episodic Cluster Headache and is currently terminated or withdrawn. Teva Branded Pharmaceutical Products R&D, Inc. leads this study, which shows 28 recorded versions since 2017 — indicating substantial longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshot~Feb 2017 – ~Apr 2017 · 59 days · monthly snapshot~Apr 2017 – ~Jun 2017 · 2 months · monthly snapshot~Jun 2017 – ~Sep 2017 · 3 months · monthly snapshot~Sep 2017 – ~Oct 2017 · 30 days · monthly snapshot~Oct 2017 – ~Jun 2018 · 8 months · monthly snapshot~Jun 2018 – ~Jul 2018 · 30 days · monthly snapshot~Jul 2018 – ~Oct 2018 · 3 months · monthly snapshot~Oct 2018 – ~Jan 2019 · 3 months · monthly snapshot~Jan 2019 – ~Apr 2019 · 3 months · monthly snapshot~Apr 2019 – ~Jul 2019 · 3 months · monthly snapshot~Jul 2019 – ~Aug 2019 · 31 days · monthly snapshot~Aug 2019 – ~Sep 2019 · 31 days · monthly snapshot~Sep 2019 – ~Oct 2019 · 30 days · monthly snapshot~Oct 2019 – ~Nov 2019 · 31 days · monthly snapshot~Nov 2019 – ~Dec 2019 · 30 days · monthly snapshot~Dec 2019 – ~Jan 2020 · 31 days · monthly snapshot~Jan 2020 – ~Feb 2020 · 31 days · monthly snapshot~Feb 2020 – ~Mar 2020 · 29 days · monthly snapshot~Mar 2020 – ~May 2020 · 2 months · monthly snapshot~May 2020 – ~Aug 2020 · 3 months · monthly snapshot~Aug 2020 – ~Nov 2020 · 3 months · monthly snapshot~Nov 2020 – ~Jan 2021 · 2 months · monthly snapshot~Jan 2021 – ~Dec 2021 · 11 months · monthly snapshot~Dec 2021 – ~Jul 2024 · 31 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshot~Sep 2025 – present · 10 months · monthly snapshot

Change History

28 versions recorded
  1. Sep 2025 — Present [monthly]

    Terminated PHASE3

  2. Sep 2024 — Sep 2025 [monthly]

    Terminated PHASE3

  3. Jul 2024 — Sep 2024 [monthly]

    Terminated PHASE3

  4. Dec 2021 — Jul 2024 [monthly]

    Terminated PHASE3

  5. Jan 2021 — Dec 2021 [monthly]

    Terminated PHASE3

Show 23 earlier versions
  1. Nov 2020 — Jan 2021 [monthly]

    Terminated PHASE3

  2. Aug 2020 — Nov 2020 [monthly]

    Terminated PHASE3

  3. May 2020 — Aug 2020 [monthly]

    Terminated PHASE3

  4. Mar 2020 — May 2020 [monthly]

    Terminated PHASE3

  5. Feb 2020 — Mar 2020 [monthly]

    Terminated PHASE3

  6. Jan 2020 — Feb 2020 [monthly]

    Terminated PHASE3

    Status: CompletedTerminated

  7. Dec 2019 — Jan 2020 [monthly]

    Completed PHASE3

    Status: TerminatedCompleted

  8. Nov 2019 — Dec 2019 [monthly]

    Terminated PHASE3

  9. Oct 2019 — Nov 2019 [monthly]

    Terminated PHASE3

  10. Sep 2019 — Oct 2019 [monthly]

    Terminated PHASE3

  11. Aug 2019 — Sep 2019 [monthly]

    Terminated PHASE3

  12. Jul 2019 — Aug 2019 [monthly]

    Terminated PHASE3

    Status: RecruitingTerminated

  13. Apr 2019 — Jul 2019 [monthly]

    Recruiting PHASE3

  14. Jan 2019 — Apr 2019 [monthly]

    Recruiting PHASE3

  15. Oct 2018 — Jan 2019 [monthly]

    Recruiting PHASE3

  16. Jul 2018 — Oct 2018 [monthly]

    Recruiting PHASE3

  17. Jun 2018 — Jul 2018 [monthly]

    Recruiting PHASE3

  18. Oct 2017 — Jun 2018 [monthly]

    Recruiting PHASE3

  19. Sep 2017 — Oct 2017 [monthly]

    Recruiting PHASE3

  20. Jun 2017 — Sep 2017 [monthly]

    Recruiting PHASE3

  21. Apr 2017 — Jun 2017 [monthly]

    Recruiting PHASE3

  22. Feb 2017 — Apr 2017 [monthly]

    Recruiting PHASE3

  23. Jan 2017 — Feb 2017 [monthly]

    Recruiting PHASE3

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Teva Branded Pharmaceutical Products R&D, Inc.
Data source: Teva Branded Pharmaceutical Products R&D, Inc.

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