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

This study has been terminated.

(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.)

Sponsor:

Information provided by (Responsible Party):

Pfizer

ClinicalTrials.gov Identifier:

NCT00372528

First received: September 5, 2006

Last updated: September 21, 2012

Last verified: September 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

September 5, 2006

Last Updated Date

September 21, 2012

Start Date ^ICMJE

March 2007

Primary Completion Date

October 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) [ Time Frame: Baseline up to Year 5 and follow-up (30 days after last dose) ] [ Designated as safety issue: Yes ]

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.

Original Primary Outcome Measures ^ICMJE

There are no primary efficacy endpoints for this study.
Safety assessments will comprise an evaluation of the type, nature, frequency and intensity of adverse events during the trial period.
No formal statistical analyses of the data will be undertaken. Only descriptive data will be presented. Standard core safety tables will be generated.

Change History

Complete list of historical versions of study NCT00372528 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Mean Number of Seizures [ 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) ] [ Designated as safety issue: No ]

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.

Original Secondary Outcome Measures ^ICMJE

No formal statistical analysis of the data will be undertaken. Descriptive data will be presented for seizure frequency (comparison of baseline partial seizure frequency with treatment partial seizure frequency).

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

An Open-Label, Multi-Center, Add-On Study Of Pregabalin (LYRICA) In Subjects With Refractory Partial Seizures Who Have Completed Studies 1008-010, 1008-035, 1008-114 Or 1008-164

Brief 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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Epilepsy

Intervention ^ICMJE

Drug: pregabalin (LYRICA)

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

Study Arm (s)

Experimental: pregabalin

open label treatment

Intervention: Drug: pregabalin (LYRICA)

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Completion Date

October 2011

Primary Completion Date

October 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Canada

Administrative Information

NCT Number ^ICMJE

NCT00372528

Other Study ID Numbers ^ICMJE

A0081140

Has Data Monitoring Committee

Responsible Party

Pfizer

Study Sponsor ^ICMJE

Pfizer

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

September 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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