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

Information source: Pfizer
Information obtained from ClinicalTrials.gov on August 08, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Epilepsy

Intervention: pregabalin (LYRICA) (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Overall contact:
Pfizer CT.gov Call Center, Phone: 1-800-718-1021

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.

Clinical Details

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

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

Primary outcome:

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.

Secondary outcome: 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).

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Pfizer CT.gov Call Center, Phone: 1-800-718-1021

Pfizer Investigational Site, Calgary, Alberta T2N 2T9, Canada; Active, not recruiting

Pfizer Investigational Site, Halifax, Nova Scotia B3H 3A7, Canada; Active, not recruiting

Pfizer Investigational Site, Windsor, Ontario N8X 5A6, Canada; Active, not recruiting

Pfizer Investigational Site, Barrie, Ontario L4M 4S5, Canada; Recruiting

Pfizer Investigational Site, Toronto, Ontario M5C 1R6, Canada; Active, not recruiting

Additional Information

To obtain contact information for a study center near you, click here.

Starting date: March 2007
Ending date: September 2009
Last updated: July 23, 2008

Page last updated: August 08, 2008

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