Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT00524030 · ClinicalTrials.gov registry record · Phase 3

Efficacy And Safety Study Of Pregabalin (Lyrica) As Monotherapy In Patients With Partial Seizures

A Phase 3 study, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris.

Terminated
Registry status
Phase 3
Development phase
161
Enrollment target

NCT00524030: Clinical Trial Phase 3 study, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris.

NCT00524030 is a Phase 3 study that was terminated before completion, run by Pfizer's Upjohn has merged with Mylan to form Viatris. The registered enrollment target is 161 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (79% lower). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT00524030, a Phase 3 study, was terminated before completion, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris.

TERMINATED
Registry status
Phase 3
Development phase
161 participants
Enrollment target

Study Summary

This study will determine the safety and efficacy of pregabalin (Lyrica) when administered by itself (without any other anti-epileptic medication) to epilepsy subjects for the treatment of partial seizures. The duration of the trial is about 6 months.

Primary Outcome

Participants who discontinued due to: episode of status epilepticus (SE); secondarily generalized tonic-clonic (SGTC) seizure if none within 2 years of study entry; 28-day study seizure rate during double-blind phase (DBP) greater than (\>)2 times maximum (Max) 28-day study seizure rate during baseline phase (BLP); 2-day study seizure rate during DBP \>2 times Max 2-day study seizure rate during BLP; or unacceptable clinically significant increase in frequency/intensity of seizure activity. Dete

Interventions

  • DRUG pregabalin 600 mg/day
  • DRUG pregabalin 150 mg/day

Trial Details

FieldValue
Enrollment Target 161 participants
Start Date 2007-09
Est. Completion 2011-06
Phase Phase 3

Why NCT00524030 stopped before completion

NCT00524030 is an interventional study that assigns participants to a tested intervention. The registered 161 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (79% lower).

The record links to 0 conditions, and to 2 interventions - of which pregabalin 600 mg/day is the first listed.

NCT00524030 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00524030 about?

NCT00524030 is a clinical study titled "Efficacy And Safety Study Of Pregabalin (Lyrica) As Monotherapy In Patients With Partial Seizures". This study will determine the safety and efficacy of pregabalin (Lyrica) when administered by itself (without any other anti-epileptic medication) to epilepsy subjects for the treatment of partial seizures. The duration of the trial is about 6 months.

What is the current status of trial NCT00524030?

This trial is currently terminated. It is a Phase 3 study. The enrollment target is 161 participants. The study started on 2007-09. Estimated completion is 2011-06.

What interventions are being tested in trial NCT00524030?

The interventions under investigation include: pregabalin 600 mg/day (DRUG), pregabalin 150 mg/day (DRUG).

Who is sponsoring clinical trial NCT00524030?

This trial is sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris, which has 158 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00524030's enrollment target sits among peer trials

161 1478th of 2000 higher than 522 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

Nationwide trials with similar profiles

Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

Similar enrollment target

  • NCT06391034 · 161 participants · Phase 2

    Magnetic Resonance (MR) Imaging With Hyperpolarized 13C-Pyruvate +/- 13C,15N-Urea in Patients With Prostate Cancer

  • NCT06546670 · 161 participants · Phase 1

    A Phase I/II Study of ITU512 in Healthy Participants and Patients With Sickle Cell Disease

  • NCT06616766 · 161 participants · Phase 1

    A Phase 1/2, Open-label, Multicenter, FIH Study to Evaluate Safety, Tolerability, PK and Anti-tumor Activity of YH42946

  • NCT06752356 · 161 participants · Phase 3

    A Study Investigating Intravenous Human Normal Immune Globulin (IGIV) 10% in Subjects With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Similar registry start date

  • NCT05988463 · started 2027-01-01 · Phase 1

    Dose-Escalation Study of Artesunate Patients With IPF

  • NCT07219706 · started 2026-12-10 · NA

    Dietary Fiber and Time Restricted Eating

  • NCT02831335 · started 2026-12-01

    Technical Development of Multi-Parametric Renocerebral MRI

  • NCT05962346 · started 2026-12 · NA

    Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

Source: ClinicalTrials.gov NCT00524030, the US trial registry maintained by the National Library of Medicine. NCT00524030 (mid enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.