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

Viatris

Status and phase: Terminated; Phase 3

Conditions: Epilepsy

Treatments: Drug: pregabalin (LYRICA)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00372528

A0081140

Details and patient eligibility

About

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.

Enrollment: 21 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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21 participants in 1 patient group

pregabalin

Experimental group

Description:

open label treatment

Treatment:

Drug: pregabalin (LYRICA)