Clinical trial NCT00150293: Evaluation of Long-Term Safety and Efficacy of Pregabalin in Patients With Partial Seizures.
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Seizure Disorder, Partial
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-08
Enrollment: 337
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: To determine long-term safety and efficacy of pregabalin in patients with partial seizures.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Cannot be pregnant or considering becoming pregnant during the course of the study.
* Cannot be receiving any concomitant medication that could alter the effectiveness of the pregabalin response or affect seizure frequency.

Primary outcomes:
measure: Safety Efficacy
Secondary outcomes:
Other outcomes:
Locations:
city: Deakin
country: Australia
facility: Pfizer Investigational Site
state: Australian Capital Territory
city: Camperdown
country: Australia
facility: Pfizer Investigational Site
state: New South Wales
city: Chastwood
country: Australia
facility: Pfizer Investigational Site
state: New South Wales
city: Cairns
country: Australia
facility: Pfizer Investigational Site
state: Queensland
city: Maroochydore
country: Australia
facility: Pfizer Investigational Site
state: Queensland
city: Footscray
country: Australia
facility: Pfizer Investigational Site
state: Victoria
city: Parkville
country: Australia
facility: Pfizer Investigational Site
state: Victoria
city: Perth
country: Australia
facility: Pfizer Investigational Site
state: Western Australia
city: Auenbruggerplatz 22
country: Austria
facility: Pfizer Investigational Site
city: Graz
country: Austria
facility: Pfizer Investigational Site
city: Innsbruck
country: Austria
facility: Pfizer Investigational Site
city: Linz
country: Austria
facility: Pfizer Investigational Site
city: Wien
country: Austria
facility: Pfizer Investigational Site
city: Leuven
country: Belgium
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: Penticton
country: Canada
facility: Pfizer Investigational Site
state: British Columbia
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: Toronto
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Windsor
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Montreal
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Montreal
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Montreal
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Regina
country: Canada
facility: Pfizer Investigational Site
state: Saskatchewan
city: Saskatoon
country: Canada
facility: Pfizer Investigational Site
state: Saskatchewan
city: Quebec
country: Canada
facility: Pfizer Investigational Site
city: Ulm
country: Germany
facility: Pfizer Investigational Site
state: BW
city: Berlin
country: Germany
facility: Pfizer Investigational Site
city: Bernau
country: Germany
facility: Pfizer Investigational Site
city: Bonn
country: Germany
facility: Pfizer Investigational Site
city: Dresden
country: Germany
facility: Pfizer Investigational Site
city: Erlangen
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: Hamburg
country: Germany
facility: Pfizer Investigational Site
city: Mainz
country: Germany
facility: Pfizer Investigational Site
city: Muenchen
country: Germany
facility: Pfizer Investigational Site
city: AE Breda
country: Netherlands
facility: Pfizer Investigational Site
city: Blaricum
country: Netherlands
facility: Pfizer Investigational Site
city: Ve Heeze
country: Netherlands
facility: Pfizer Investigational Site
city: Bialystok
country: Poland
facility: Pfizer Investigational Site
city: Bydgoszcz
country: Poland
facility: Pfizer Investigational Site
city: Choroszcz
country: Poland
facility: Pfizer Investigational Site
city: Gdansk
country: Poland
facility: Pfizer Investigational Site
city: Gdansk
country: Poland
facility: Pfizer Investigational Site
city: Grudziadz
country: Poland
facility: Pfizer Investigational Site
city: Katowice
country: Poland
facility: Pfizer Investigational Site
city: Krakow
country: Poland
facility: Pfizer Investigational Site
city: Lublin
country: Poland
facility: Pfizer Investigational Site
city: Mosina
country: Poland
facility: Pfizer Investigational Site
city: Olsztyn
country: Poland
facility: Pfizer Investigational Site
city: Plock
country: Poland
facility: Pfizer Investigational Site
city: Poznan
country: Poland
facility: Pfizer Investigational Site
city: Poznan
country: Poland
facility: Pfizer Investigational Site
city: Torun
country: Poland
facility: Pfizer Investigational Site
city: Warsaw
country: Poland
facility: Pfizer Investigational Site
city: Warsaw
country: Poland
facility: Pfizer Investigational Site
city: Warszawa
country: Poland
facility: Pfizer Investigational Site
city: Warszawa
country: Poland
facility: Pfizer Investigational Site
city: Coimbra
country: Portugal
facility: Pfizer Investigational Site
city: Porto
country: Portugal
facility: Pfizer Investigational Site
city: Barcelona
country: Spain
facility: Pfizer Investigational Site
city: Girona
country: Spain
facility: Pfizer Investigational Site
city: Granada
country: Spain
facility: Pfizer Investigational Site
city: Madrid
country: Spain
facility: Pfizer Investigational Site
city: Madrid
country: Spain
facility: Pfizer Investigational Site
city: Malaga
country: Spain
facility: Pfizer Investigational Site
city: Zaragoza
country: Spain
facility: Pfizer Investigational Site
city: Middlesborough
country: United Kingdom
facility: Pfizer Investigational Site
state: N. York
city: Washington
country: United Kingdom
facility: Pfizer Investigational Site
state: Tyne & Wear
city: Blackpool
country: United Kingdom
facility: Pfizer Investigational Site
city: Dundee
country: United Kingdom
facility: Pfizer Investigational Site
city: Glasgow
country: United Kingdom
facility: Pfizer Investigational Site
city: Leeds
country: United Kingdom
facility: Pfizer Investigational Site
city: London
country: United Kingdom
facility: Pfizer Investigational Site
city: Northampton
country: United Kingdom
facility: Pfizer Investigational Site
city: Wolverhampton
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: