To Evaluate the Long-Term Safety of Pregabalin in Refractory Partial Epilepsy.

This study has been completed.

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00141414

Purpose

To evaluate the long-term safety of pregabalin in refractory partial epilepsy.

Condition	Intervention	Phase
Epilepsy, Partial	Drug: Pregabalin	Phase II

MedlinePlus related topics: Epilepsy

Drug Information available for: Pregabalin

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title:	Pregabablin Open-Label, Follow-On Safety Trial In Patients With Refractory Partial Epilepsy.

Further study details as provided by Pfizer:

Primary Outcome Measures:

Estimated Enrollment:	82
Study Start Date:	November 1997
Estimated Study Completion Date:	October 2005

Eligibility

Criteria

Inclusion Criteria:

Must have met the inclusion criteria for preceding double-blind study.
Have received double-blind study medication and wish to receive open-label pregabalin.

Exclusion Criteria:

Pregnant or considering becoming pregnant.
Receiving any concomitant medication that could alter the effectiveness of their medication response or seizure frequency.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00141414

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Link to ClinicalStudyResults.org Posting This link exits the ClinicalTrials.gov site

Study ID Numbers:	1008-008
Study First Received:	August 30, 2005
Last Updated:	December 28, 2006
ClinicalTrials.gov Identifier:	NCT00141414
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Epilepsies, Partial
Epilepsy
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 13, 2009