Clinical trial NCT00596466: Extension Study Of Long-Term Safety And Efficacy Of Pregabalin As Monotherapy (Lyrica) In Patients With Partial Seizures
Official title: An Open-Label Multicenter Extension Study To Determine Long Term Safety And Efficacy Of Pregabalin (Lyrica) As Monotherapy In Patients With Partial Seizures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Epilepsy
Keywords: open-label
extension study
pregabalin
partial epilepsy
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-01-17
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will evaluate the long term safety and efficacy of pregabalin (Lyrica) when administered by itself (without any other anti-epileptic medication) to epilepsy patients for the treatment of partial seizures. This is an extension study to a previous clinical trial.


Eligibility criteria: Inclusion Criteria:

* Completed the previous protocol and wish to continue to receive pregabalin.
* Diagnosis of epilepsy with partial seizures

Exclusion Criteria:

* Early withdrawal from the previous protocol, an episode of status epliepticus, or primary generalized epilepsy.

Primary outcomes:
measure: Seizure Frequency
timeFrame: Baseline up to Week 28
measure: Number of Participants With (All Causality) Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Baseline up to Week 28
measure: Number of Participants With Laboratory Test Values of Potential Clinical Importance
timeFrame: Baseline up to Week 28
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Fayetteville
country: United States
facility: Pfizer Investigational Site
state: Arkansas
city: Fullerton
country: United States
facility: Pfizer Investigational Site
state: California
city: Long Beach
country: United States
facility: Pfizer Investigational Site
state: California
city: Modesto
country: United States
facility: Pfizer Investigational Site
state: California
city: Murrieta
country: United States
facility: Pfizer Investigational Site
state: California
city: Newport Beach
country: United States
facility: Pfizer Investigational Site
state: California
city: Temecula
country: United States
facility: Pfizer Investigational Site
state: California
city: Denver
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: Jacksonville
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Suwanee
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Danville
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Fort Wayne
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Kansas City
country: United States
facility: Pfizer Investigational Site
state: Kansas
city: Bowling Green
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: Lexington
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: Houma
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: Shreveport
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: Pikesville
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Worcester
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Detroit
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Flowood
country: United States
facility: Pfizer Investigational Site
state: Mississippi
city: Great Falls
country: United States
facility: Pfizer Investigational Site
state: Montana
city: Charlotte
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Charlotte
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Columbus
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Oklahoma City
country: United States
facility: Pfizer Investigational Site
state: Oklahoma
city: Oklahoma City
country: United States
facility: Pfizer Investigational Site
state: Oklahoma
city: Dallas
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Houston
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Temple
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Salt Lake City
country: United States
facility: Pfizer Investigational Site
state: Utah
city: West Jordan
country: United States
facility: Pfizer Investigational Site
state: Utah
city: Milwaukee
country: United States
facility: Pfizer Investigational Site
state: Wisconsin
city: Beroun
country: Czechia
facility: Pfizer Investigational Site
city: Brno 2
country: Czechia
facility: Pfizer Investigational Site
city: Litomysl
country: Czechia
facility: Pfizer Investigational Site
city: New Territories
country: Hong Kong
facility: Pfizer Investigational Site
city: Dnipropetrovsk
country: Ukraine
facility: Pfizer Investigational Site
city: Dnipropetrovsk
country: Ukraine
facility: Pfizer Investigational Site
city: Kharkiv
country: Ukraine
facility: Pfizer Investigational Site
city: Kharkiv
country: Ukraine
facility: Pfizer Investigational Site
city: Lugansk
country: Ukraine
facility: Pfizer Investigational Site
city: Odessa
country: Ukraine
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: