Efficacy And Safety Study Of Pregabalin (Lyrica) As Monotherapy In Patients With Partial Seizures - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00524030

Purpose

This study will determine the safety and efficacy of pregabalin (Lyrica) when administered by itself (without any other anti-epileptic medication) to epilepsy subjects for the treatment of partial seizures. The duration of the trial is about 6 months.

Condition	Intervention	Phase
Epilepsies, Partial	Drug: pregabalin 600 mg/day Drug: pregabalin 150 mg/day	Phase III

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, Investigator), Parallel Assignment, Safety/Efficacy Study
Official Title:	A Double-Blind, Randomized, Multicenter Efficacy And Safety Study Of Pregabalin (Lyrica) As Monotherapy In Patients With Partial Seizures

Further study details as provided by Pfizer:

Primary Outcome Measures:

The percent of subjects who meet at least one of the 5 pre-specified exit criteria (which reflect a decrease in seizure control) during double-blind treatment. [ Time Frame: during 18 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Pregabalin population PK and exposure-response analysis. [ Time Frame: during 20 weeks ] [ Designated as safety issue: No ]
Percent of subjects exiting by group. [ Time Frame: during 18 weeks ] [ Designated as safety issue: No ]
Percent of subjects completing double-blind treatment. [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
Percent of subjects seizure-free during: the last study month, the monotherapy phase, and the entire double-blind treatment phase. [ Time Frame: 4, 12 and 20 weeks ] [ Designated as safety issue: No ]
Percent of subjects who met each of the exit events. [ Time Frame: during 18 weeks ] [ Designated as safety issue: No ]
Mean time on pregabalin monotherapy. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	250
Study Start Date:	September 2007
Estimated Study Completion Date:	March 2010
Estimated Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: pregabalin 600 mg/day pregabalin 600 mg/day (300mg BID), duration is 20 weeks.
2: Experimental	Drug: pregabalin 150 mg/day pregabalin 150 mg/day (75mg BID), duration is 20 weeks.

Eligibility

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

Criteria

Inclusion Criteria:

Diagnosis of epilepsy with partial seizures.
Males or females, age 18 years or older.
Documented history of at least 4 partial seizures in the 8 weeks prior to the screening visit.
Stable treatment with 1 to 2 anti-epileptic drugs in the 8 weeks prior to the screening visit.

Exclusion Criteria:

Current diagnosis of febrile seizures or seizures related to an ongoing acute medical event.
Seizures occurring only in cluster patterns, or seizures of a metabolic, toxic or infectious origin.
Primary generalized epilepsy or status epileptics within the previous year.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00524030

Contacts

Contact: Pfizer CT.gov Call Center

1-800-718-1021

Show 63 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:	A0081047
Study First Received:	August 30, 2007
Last Updated:	January 12, 2009
ClinicalTrials.gov Identifier:	NCT00524030
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

Epilepsy, partial seizures, pregabalin monotherapy, double-blind and randomized trial

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