deltatrials
Completed PHASE3 INTERVENTIONAL 1-arm NCT01463306

A 12-Month Study To Evaluate The Safety And Tolerability Of Pregabalin As Add-On Therapy In Pediatric Subjects 1 Month To 16 Years Of Age With Partial Onset Seizures And Pediatric And Adult Subjects 5 To 65 Years Of Age With Primary Generalized Tonic-Clonic Seizures

A 12-MONTH OPEN-LABEL STUDY TO EVALUATE THE SAFETY AND TOLERABILITY OF PREGABALIN AS ADJUNCTIVE THERAPY IN PEDIATRIC SUBJECTS 1 MONTH TO 16 YEARS OF AGE WITH PARTIAL ONSET SEIZURES AND PEDIATRIC AND ADULT SUBJECTS 5 TO 65 YEARS OF AGE WITH PRIMARY GENERALIZED TONIC-CLONIC SEIZURES

Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Interventions Pregabalin
Updated 39 times since 2017 Last updated: Jan 15, 2021 Started: Feb 21, 2012 Primary completion: Aug 22, 2019 Completion: Aug 22, 2019
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT01463306, this PHASE3 trial focuses on Epilepsy, Partial Seizures and Epilepsy, Primary Generalized Tonic-Clonic Seizures and remains completed. Sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris Inc., it has been updated 39 times since 2012, reflecting substantial change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshot~Feb 2017 – ~Apr 2017 · 59 days · monthly snapshot~Apr 2017 – ~May 2017 · 30 days · monthly snapshot~May 2017 – ~Jun 2017 · 31 days · monthly snapshot~Jun 2017 – ~Aug 2017 · 2 months · monthly snapshot~Aug 2017 – ~Sep 2017 · 31 days · 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 – ~Feb 2018 · 2 months · monthly snapshot~Feb 2018 – ~Mar 2018 · 28 days · monthly snapshot~Mar 2018 – ~Apr 2018 · 31 days · monthly snapshot~Apr 2018 – ~May 2018 · 30 days · monthly snapshot~May 2018 – ~Jun 2018 · 31 days · 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 – ~Dec 2018 · 30 days · monthly snapshot~Dec 2018 – ~Jan 2019 · 31 days · monthly snapshot~Jan 2019 – ~Feb 2019 · 31 days · monthly snapshot~Feb 2019 – ~Mar 2019 · 28 days · monthly snapshot~Mar 2019 – ~Apr 2019 · 31 days · monthly snapshot~Apr 2019 – ~May 2019 · 30 days · monthly snapshot~May 2019 – ~Jul 2019 · 2 months · monthly snapshot~Jul 2019 – ~Aug 2019 · 31 days · monthly snapshot~Aug 2019 – ~Oct 2019 · 2 months · monthly snapshot~Oct 2019 – ~Dec 2019 · 2 months · monthly snapshot~Dec 2019 – ~Jan 2020 · 31 days · monthly snapshot~Jan 2020 – ~Mar 2020 · 2 months · monthly snapshot~Mar 2020 – ~Sep 2020 · 6 months · monthly snapshot~Sep 2020 – ~Jan 2021 · 4 months · monthly snapshot~Jan 2021 – ~Feb 2021 · 31 days · monthly snapshot~Feb 2021 – ~Dec 2021 · 10 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

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

    Completed PHASE3

  2. Sep 2024 — Sep 2025 [monthly]

    Completed PHASE3

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE3

  4. Dec 2021 — Jul 2024 [monthly]

    Completed PHASE3

  5. Feb 2021 — Dec 2021 [monthly]

    Completed PHASE3

Show 34 earlier versions
  1. Jan 2021 — Feb 2021 [monthly]

    Completed PHASE3

  2. Sep 2020 — Jan 2021 [monthly]

    Completed PHASE3

  3. Mar 2020 — Sep 2020 [monthly]

    Completed PHASE3

  4. Jan 2020 — Mar 2020 [monthly]

    Completed PHASE3

  5. Dec 2019 — Jan 2020 [monthly]

    Completed PHASE3

  6. Oct 2019 — Dec 2019 [monthly]

    Completed PHASE3

    Status: Active Not RecruitingCompleted

  7. Aug 2019 — Oct 2019 [monthly]

    Active Not Recruiting PHASE3

  8. Jul 2019 — Aug 2019 [monthly]

    Active Not Recruiting PHASE3

    Status: RecruitingActive Not Recruiting

  9. May 2019 — Jul 2019 [monthly]

    Recruiting PHASE3

  10. Apr 2019 — May 2019 [monthly]

    Recruiting PHASE3

  11. Mar 2019 — Apr 2019 [monthly]

    Recruiting PHASE3

  12. Feb 2019 — Mar 2019 [monthly]

    Recruiting PHASE3

  13. Jan 2019 — Feb 2019 [monthly]

    Recruiting PHASE3

  14. Dec 2018 — Jan 2019 [monthly]

    Recruiting PHASE3

  15. Nov 2018 — Dec 2018 [monthly]

    Recruiting PHASE3

  16. Oct 2018 — Nov 2018 [monthly]

    Recruiting PHASE3

  17. Sep 2018 — Oct 2018 [monthly]

    Recruiting PHASE3

  18. Aug 2018 — Sep 2018 [monthly]

    Recruiting PHASE3

  19. Jul 2018 — Aug 2018 [monthly]

    Recruiting PHASE3

  20. Jun 2018 — Jul 2018 [monthly]

    Recruiting PHASE3

  21. May 2018 — Jun 2018 [monthly]

    Recruiting PHASE3

  22. Apr 2018 — May 2018 [monthly]

    Recruiting PHASE3

  23. Mar 2018 — Apr 2018 [monthly]

    Recruiting PHASE3

  24. Feb 2018 — Mar 2018 [monthly]

    Recruiting PHASE3

  25. Dec 2017 — Feb 2018 [monthly]

    Recruiting PHASE3

  26. Nov 2017 — Dec 2017 [monthly]

    Recruiting PHASE3

  27. Oct 2017 — Nov 2017 [monthly]

    Recruiting PHASE3

  28. Sep 2017 — Oct 2017 [monthly]

    Recruiting PHASE3

  29. Aug 2017 — Sep 2017 [monthly]

    Recruiting PHASE3

  30. Jun 2017 — Aug 2017 [monthly]

    Recruiting PHASE3

  31. May 2017 — Jun 2017 [monthly]

    Recruiting PHASE3

  32. Apr 2017 — May 2017 [monthly]

    Recruiting PHASE3

  33. Feb 2017 — Apr 2017 [monthly]

    Recruiting PHASE3

  34. Jan 2017 — Feb 2017 [monthly]

    Recruiting PHASE3

    First recorded

Feb 2012

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Data source: Pfizer

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