deltatrials
Completed PHASE3 NCT00113815

Topiramate as Adjunctive Therapy in Infants 1-24 Months for the Control of Partial Onset Seizures

A Randomized, Double-Blind, Placebo-Controlled, Fixed Dose-Ranging Study to Assess the Safety, Tolerability, and Efficacy of Topiramate Oral Liquid and Sprinkle Formulations as an Adjunct to Concurrent Anticonvulsant Therapy for Infants (1-24 Months of Age) With Refractory Partial-Onset Seizures

Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Updated 7 times since 2017 Last updated: Mar 25, 2014 Started: May 31, 2005 Primary completion: Jun 30, 2007 Completion: Nov 30, 2007

A PHASE3 clinical study on Epilepsy and Partial Seizure Disorder, this trial is completed. The trial is conducted by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. and has accumulated 7 data snapshots since 2005. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshotCompleted~Feb 2017 – ~Jun 2018 · 16 months · monthly snapshotCompleted~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotCompleted~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshotCompleted~Sep 2025 – present · 7 months · monthly snapshotCompleted

Change History

7 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. Jan 2021 — Jul 2024 [monthly]

    Completed PHASE3

  5. Jun 2018 — Jan 2021 [monthly]

    Completed PHASE3

Show 2 earlier versions
  1. Feb 2017 — Jun 2018 [monthly]

    Completed PHASE3

  2. Jan 2017 — Feb 2017 [monthly]

    Completed PHASE3

    First recorded

May 2005

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Data source: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

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