To Evaluate the Long-Term Safety and Efficacy of Pregabalin in Patients With Partial Seizures

This study has been completed.

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00141388

Purpose

To evaluate the long-term safety and efficacy of pregabalin in patients with partial seizures.

Condition	Intervention	Phase
Seizure Disorder, Partial	Drug: Pregabalin	Phase III

MedlinePlus related topics: Epilepsy Seizures

Drug Information available for: Pregabalin

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Pregabalin Open-Label Add-On Trial: An Open-Label, Multicenter Follow-On Study to Determine Long-Term Safety and Efficacy in Patients With Partial Seizures.

Further study details as provided by Pfizer:

Primary Outcome Measures:

Estimated Enrollment:	500
Study Start Date:	July 1998
Estimated Study Completion Date:	October 2005

Eligibility

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00141388

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:	1008-010
Study First Received:	August 30, 2005
Last Updated:	December 28, 2006
ClinicalTrials.gov Identifier:	NCT00141388
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Epilepsies, Partial
Signs and Symptoms
Epilepsy
Seizures

Pregabalin
Neurologic Manifestations
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