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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

September 5, 2006

Last Updated Date

May 6, 2009

Start Date ^†

March 2007

Current Primary Outcome Measures ^†

There are no primary efficacy endpoints for this study. [ Time Frame: 30 months ] [ Designated as safety issue: No ]
Safety assessments will comprise an evaluation of the type, nature, frequency and intensity of adverse events during the trial period. [ Time Frame: 30 months ] [ Designated as safety issue: Yes ]
No formal statistical analyses of the data will be undertaken. Only descriptive data will be presented. Standard core safety tables will be generated. [ Time Frame: 30 months ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^†

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 ^†

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). [ Time Frame: 30 months ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

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

Official Title ^†

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

Study Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study

Condition ^†

Epilepsy

Intervention ^†

Drug: pregabalin (LYRICA)

Study Arms / Comparison Groups

Experimental: open label treatment

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Active, not recruiting

Estimated Enrollment ^†

Estimated Completion Date

September 2009

Estimated Primary Completion Date

September 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^†

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 ^††

Location Countries ^†

Canada

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00372528

Responsible Party

Director, Clinical Trials Disclosure Group, Pfizer, Inc.

Secondary IDs ^††

Study Sponsor ^†

Pfizer

Collaborators ^††

Investigators ^†

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

May 2009

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.