Visual Field Assessment With Subjects Who Receive Either Lyrica Or Sugar Pills - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00351611

Purpose

Epileptic partial seizure subjects will be assigned to take either Lyrica 300 mg per day or placebo which is a sugar pill with no active ingredients in it for 3 months. Neither the study doctor or nor the subject knows what he/she has been assigned to. By the end of the treatment the person's visual field test results will be compared to the one test collected at the beginning, prior to taking the study drug to see if there are any changes.

Condition	Intervention	Phase
Epilepsies, Partial	Drug: Lyrica (pregabalin) Drug: placebo	Phase IV

Genetics Home Reference related topics: autosomal dominant partial epilepsy with auditory features 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, Randomized, Double Blind (Subject, Caregiver), Parallel Assignment, Safety Study
Official Title:	Prospective Randomized 12-Week Controlled Study Of Visual Field Change In Subjects With Partial Seizures Receiving Pregabalin Or Placebo

Further study details as provided by Pfizer:

Primary Outcome Measures:

Visual field changes, if there is any, while comparing before and after the study drug or placebo consumption will be assessed. [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Visual acuity will be assessed at the beginning and end of the study as well. [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	284
Study Start Date:	July 2006
Estimated Study Completion Date:	June 2010
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active: Experimental Active drug	Drug: Lyrica (pregabalin) 150 mg twice a day, oral administration
Placebo: Placebo Comparator placebo comparator	Drug: placebo Twice a day, oral administration

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Epilepsy partial seizure subjects

Exclusion Criteria:

Pre-existing eye diseases

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00351611

Contacts

Contact: Pfizer CT.gov Call Center

1-800-718-1021

Show 33 Study Locations

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:	A0081096
Study First Received:	July 11, 2006
Last Updated:	December 18, 2008
ClinicalTrials.gov Identifier:	NCT00351611
Health Authority:	United States: Institutional Review Board

Keywords provided by Pfizer:

Epilepsy partial seizure treament with pregabalin or placebo, visual field assessment

Study placed in the following topic categories:

Epilepsies, Partial
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