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

Phase 3TerminatedNCT00372528

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.21 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Epilepsy

Interventions

pregabalin (LYRICA)DRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (5)

Pfizer Investigational Site

Calgary, Alberta, Canada

Pfizer Investigational Site

Halifax, Nova Scotia, Canada

Pfizer Investigational Site

Barrie, Ontario, Canada

Pfizer Investigational Site

Toronto, Ontario, Canada

Outcomes

Primary Outcomes

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

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state.

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

Secondary Outcomes

Mean Number of Seizures

Seizures were episodes of disturbed brain activity that cause changes in attention or behavior. The different types of seizures observed were complex partial, secondarily generalized tonic-clonic, simple partial and others. Mean number of seizures were calculated between each study visit.

Time frame: Month 6 thereafter every 6 months up to Month 54 or End of Study (EOS) and follow-up (30 days after last dose)

Data from ClinicalTrials.gov

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