Clinical trial NCT00143143: Pregabalin Open-Label Extension Trial in Patients With Partial Seizures
Official title: Pregabalin BID Open-Label Add-On Trial: A Follow-Up Study To Determine Long-Term Safety and Efficacy in Patients With Partial Seizures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Epilepsies, Partial
Epilepsy, Complex Partial
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-02
Enrollment: 300
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: The primary purpose of the protocol is to evaluate the long-term safety of pregabalin in patients with partial seizures.


Eligibility criteria: Inclusion Criteria:

* Patients must have met the inclusion criteria for Study 1008-157, have received double-blind study medication, and wish to receive open-label pregabalin
* Have the diagnosis of epilepsy with partial seizures and have a minimum of 4 partial seizures during the 6 weeks prior to screening
* Be currently taking 1 to 3 AEDs.

Exclusion Criteria:

* Have a treatable cause of seizures
* Experienced a serious adverse event during Study 1008-157 which was determined to be possibly related to study medication

Primary outcomes:
measure: Safety assessments are performed at quarterly visits up until the study is closed.
Secondary outcomes:
measure: Seizure frequency is assessed throughout the study until the study is closed.
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: Pfizer Investigational Site
city: Mauer Bei Amstetten
country: Austria
facility: Pfizer Investigational Site
city: St Polten
country: Austria
facility: Pfizer Investigational Site
city: Wien
country: Austria
facility: Pfizer Investigational Site
city: Calgary
country: Canada
facility: Pfizer Investigational Site
state: Alberta
city: Edmonton
country: Canada
facility: Pfizer Investigational Site
state: Alberta
city: Vancouver
country: Canada
facility: Pfizer Investigational Site
state: British Columbia
city: Halifax
country: Canada
facility: Pfizer Investigational Site
state: Nova Scotia
city: Barrie
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: London
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Ottawa
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Trois Rivieres
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Marseille
country: France
facility: Pfizer Investigational Site
state: Cedex 05
city: Paris
country: France
facility: Pfizer Investigational Site
state: Cedex 13
city: Montpellier
country: France
facility: Pfizer Investigational Site
state: Cedex 5
city: Lille
country: France
facility: Pfizer Investigational Site
state: Cedex
city: Rennes
country: France
facility: Pfizer Investigational Site
state: Cedex
city: Colomiers
country: France
facility: Pfizer Investigational Site
city: Dommartin Les Toul
country: France
facility: Pfizer Investigational Site
city: Marseille Cedex 09
country: France
facility: Pfizer Investigational Site
city: Strasbourg
country: France
facility: Pfizer Investigational Site
city: Berlin
country: Germany
facility: Pfizer Investigational Site
city: Berlin
country: Germany
facility: Pfizer Investigational Site
city: Bielefeld
country: Germany
facility: Pfizer Investigational Site
city: Bonn
country: Germany
facility: Pfizer Investigational Site
city: Essen
country: Germany
facility: Pfizer Investigational Site
city: Frankfurt
country: Germany
facility: Pfizer Investigational Site
city: Freiburg
country: Germany
facility: Pfizer Investigational Site
city: Goettingen
country: Germany
facility: Pfizer Investigational Site
city: Kehl
country: Germany
facility: Pfizer Investigational Site
city: Marburg
country: Germany
facility: Pfizer Investigational Site
city: ULM
country: Germany
facility: Pfizer Investigational Site
city: Firenze
country: Italy
facility: Pfizer Investigational Site
city: Perugia
country: Italy
facility: Pfizer Investigational Site
city: Pisa
country: Italy
facility: Pfizer Investigational Site
city: Siena
country: Italy
facility: Pfizer Investigational Site
city: Vilnius
country: Lithuania
facility: Pfizer Investigational Site
city: Vilnius
country: Lithuania
facility: Pfizer Investigational Site
city: Barcelona
country: Spain
facility: Pfizer Investigational Site
city: Donostia-San Sebastian
country: Spain
facility: Pfizer Investigational Site
city: Gerona
country: Spain
facility: Pfizer Investigational Site
city: Madrid
country: Spain
facility: Pfizer Investigational Site
city: Madrid
country: Spain
facility: Pfizer Investigational Site
city: Glascow
country: United Kingdom
facility: Pfizer Investigational Site
state: Scotland
city: Fazakerley, Liverpool
country: United Kingdom
facility: Pfizer Investigational Site
city: York
country: United Kingdom
facility: Pfizer Investigational Site
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: