deltatrials
Completed PHASE2 INTERVENTIONAL 4-arm NCT03160898

A Study to Evaluate Efficacy, Safety and Tolerability of CK-2127107 in Patients With Amyotrophic Lateral Sclerosis (ALS) (FORTITUDE-ALS)

A Phase 2, Multi-Center, Double-Blind, Randomized, Dose-Ranging, Placebo-Controlled Study to Evaluate the Efficacy, Safety and Tolerability of CK-2127107 in Patients With Amyotrophic Lateral Sclerosis (ALS)

Sponsor: Astellas Pharma Inc

Conditions Amyotrophic Lateral Sclerosis
Interventions Placebo Reldesemtiv
Updated 24 times since 2017 Last updated: Aug 21, 2020 Started: Jul 24, 2017 Primary completion: Mar 7, 2019 Completion: Mar 7, 2019
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT03160898, this PHASE2 trial focuses on Amyotrophic Lateral Sclerosis and remains completed. Sponsored by Astellas Pharma Inc, it has been updated 24 times since 2017, reflecting substantial change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Status Flow

~Jun 2017 – ~Sep 2017 · 3 months · monthly snapshot~Sep 2017 – ~Oct 2017 · 30 days · monthly snapshot~Oct 2017 – ~Nov 2017 · 31 days · monthly snapshot~Nov 2017 – ~Dec 2017 · 30 days · monthly snapshot~Dec 2017 – ~Jan 2018 · 31 days · monthly snapshot~Jan 2018 – ~Feb 2018 · 31 days · monthly snapshot~Feb 2018 – ~Mar 2018 · 28 days · monthly snapshot~Mar 2018 – ~Apr 2018 · 31 days · monthly snapshot~Apr 2018 – ~Jun 2018 · 2 months · monthly snapshot~Jun 2018 – ~Jul 2018 · 30 days · monthly snapshot~Jul 2018 – ~Aug 2018 · 31 days · monthly snapshot~Aug 2018 – ~Sep 2018 · 31 days · monthly snapshot~Sep 2018 – ~Oct 2018 · 30 days · monthly snapshot~Oct 2018 – ~Nov 2018 · 31 days · monthly snapshot~Nov 2018 – ~Mar 2019 · 4 months · monthly snapshot~Mar 2019 – ~Apr 2019 · 31 days · monthly snapshot~Apr 2019 – ~May 2019 · 30 days · monthly snapshot~May 2019 – ~Mar 2020 · 10 months · monthly snapshot~Mar 2020 – ~Oct 2020 · 7 months · monthly snapshot~Oct 2020 – ~Jan 2021 · 3 months · monthly snapshot~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshot~Sep 2025 – present · 11 months · monthly snapshot

Change History

24 versions recorded

  1. Sep 2025 — Present [monthly]

    Completed PHASE2

  2. Sep 2024 — Sep 2025 [monthly]

    Completed PHASE2

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE2

  4. Jan 2021 — Jul 2024 [monthly]

    Completed PHASE2

  5. Oct 2020 — Jan 2021 [monthly]

    Completed PHASE2

▶ Show 19 earlier versions

  1. Mar 2020 — Oct 2020 [monthly]

    Completed PHASE2

  2. May 2019 — Mar 2020 [monthly]

    Completed PHASE2

    Status: Active Not Recruiting → Completed

  3. Apr 2019 — May 2019 [monthly]

    Active Not Recruiting PHASE2

  4. Mar 2019 — Apr 2019 [monthly]

    Active Not Recruiting PHASE2

    Status: Recruiting → Active Not Recruiting

  5. Nov 2018 — Mar 2019 [monthly]

    Recruiting PHASE2

  6. Oct 2018 — Nov 2018 [monthly]

    Recruiting PHASE2

  7. Sep 2018 — Oct 2018 [monthly]

    Recruiting PHASE2

  8. Aug 2018 — Sep 2018 [monthly]

    Recruiting PHASE2

  9. Jul 2018 — Aug 2018 [monthly]

    Recruiting PHASE2

  10. Jun 2018 — Jul 2018 [monthly]

    Recruiting PHASE2

  11. Apr 2018 — Jun 2018 [monthly]

    Recruiting PHASE2

  12. Mar 2018 — Apr 2018 [monthly]

    Recruiting PHASE2

  13. Feb 2018 — Mar 2018 [monthly]

    Recruiting PHASE2

  14. Jan 2018 — Feb 2018 [monthly]

    Recruiting PHASE2

  15. Dec 2017 — Jan 2018 [monthly]

    Recruiting PHASE2

  16. Nov 2017 — Dec 2017 [monthly]

    Recruiting PHASE2

  17. Oct 2017 — Nov 2017 [monthly]

    Recruiting PHASE2

  18. Sep 2017 — Oct 2017 [monthly]

    Recruiting PHASE2

    Status: Not Yet Recruiting → Recruiting

  19. Jun 2017 — Sep 2017 [monthly]

    Not Yet Recruiting PHASE2

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Astellas Pharma Inc
  • Cytokinetics
Data source: Cytokinetics

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

Study Locations

Ann Arbor, United States , Atlanta, United States , Aurora, United States , Baltimore, United States , Bedford Park, Australia , Burlington, United States , Calgary, Canada , Camperdown, Australia , Charlotte, United States , Charlottesville, United States and 50 more locations