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

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00372528

Purpose

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.

Condition	Intervention	Phase
Epilepsy	Drug: pregabalin (LYRICA)	Phase III

Genetics Home Reference related topics: pyridoxal 5'-phosphate-dependent epilepsy pyridoxine-dependent epilepsy

MedlinePlus related topics: Epilepsy Seizures

Drug Information available for: Pregabalin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study
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

Further study details as provided by Pfizer:

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 ]

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 ]

Estimated Enrollment:	35
Study Start Date:	March 2007
Estimated Study Completion Date:	September 2009
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
pregabalin: Experimental open label treatment	Drug: pregabalin (LYRICA) 150 mg up to a maximum of 600 mg per day bid or tid as required

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00372528

Locations

Canada, Alberta
Pfizer Investigational Site
Calgary, Alberta, Canada, T2N 2T9
Canada, Nova Scotia
Pfizer Investigational Site
Halifax, Nova Scotia, Canada, B3H 3A7
Canada, Ontario
Pfizer Investigational Site
Windsor, Ontario, Canada, N8X 5A6
Pfizer Investigational Site
Barrie, Ontario, Canada, L4M 4S5
Pfizer Investigational Site
Toronto, Ontario, Canada, M5C 1R6

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trials Disclosure Group )
Study ID Numbers:	A0081140
Study First Received:	September 5, 2006
Last Updated:	January 8, 2009
ClinicalTrials.gov Identifier:	NCT00372528
Health Authority:	Canada: Health Canada

Study placed in the following topic categories:

Epilepsy
Seizures
Pregabalin
Central Nervous System Diseases
Brain Diseases

Additional relevant MeSH terms:

Sensory System Agents
Therapeutic Uses
Physiological Effects of Drugs
Nervous System Diseases
Peripheral Nervous System Agents

Analgesics
Central Nervous System Agents
Anticonvulsants
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009