TerminatedPhase 3

An Open-Label Study Of Pregabalin In Subjects With Refractory Partial Seizures

Stopped: This study was terminated on April 8, 2011 as Pfizer Canada could no longer supply study drug. No efficacy or safety concerns factored into this decision.

Canada21 participantsStarted 2007-03

Plain-language summary

The main purpose of this trial is to allow continued access to pregabalin to Canadian subjects who participated in global pregabalin epilepsy studies 1008-010; 1008-035; 1008-114 and 1008-164 and to continue to study the long term safety of pregabalin administered as adjunctive therapy at dosages from 150 mg/day to 600 mg/day in Canadian subjects with refractory partial seizures.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Must have completed Pfizer open-label studies 1008-010; 1008-035; 1008-114 or 1008-164 and wishes to continue receiving open-label pregabalin * Must have responded favorably to pregabalin in Pfizer open-label study 1008-010, 1008-035, 1008-114 or 1008-164 and in the clinical opinion of the investigator continued treatment with pregabalin is in the the patient's best medical interest Exclusion Criteria: * Is pregnant or is considering becoming pregnant during the course of the study * Experienced a serious adverse event during open-label Pfizer study 1008-010, 1008-035, 1008-114 or 1008-164

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)

Timeframe: Baseline up to Year 5 and follow-up (30 days after last dose)

Trial details

NCT IDNCT00372528

SponsorPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2011-10

Results submitted2012-09-21

View on ClinicalTrials.gov More Epilepsy trials