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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2011-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT00524030

Epilepsies, Partial

TERMINATED PHASE3

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

NCT00596466

Epilepsy

COMPLETED PHASE3

Lyrica (Pregabalin) Administered as an Add-on Therapy for Partial Seizures (LEADER).

NCT00288639

Epilepsy

COMPLETED PHASE4

Study Of The Safety And Efficacy Of Lyrica In The Treatment Of Newly Diagnosed Partial Epilepsy

NCT00280059

Epilepsy, Partial

COMPLETED PHASE3

Non-Interventional Study With LYRICA (Pregabalin) In Patients With Epilepsy As Adjunctive Therapy Of Partial Seizures To Reduce Seizure Frequency

NCT00684424

Epilepsy

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Epilepsy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

pregabalin

open label treatment

Group Type EXPERIMENTAL

pregabalin (LYRICA)

Intervention Type DRUG

150 mg up to a maximum of 600 mg per day bid or tid as required

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

pregabalin (LYRICA)

150 mg up to a maximum of 600 mg per day bid or tid as required

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No