Clinical trial NCT00141245: To Evaluate Long-Term Safety and Efficacy of Pregabalin in Patients With Partial Seizures.
Official title: Pregabalin Open-Label, Multicenter Add-On Trial Following a 4-Day Double-Blind Transition Period 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: 2005-09-01
Enrollment: 325
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 evaluate 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 have absence seizures

Primary outcomes:
measure: Safety Efficacy
Secondary outcomes:
Other outcomes:
Locations:
city: Deakin
country: Australia
facility: Pfizer Investigational Site
state: Australian Capital Territory
city: Chatswood
country: Australia
facility: Pfizer Investigational Site
state: New South Wales
city: Westmead
country: Australia
facility: Pfizer Investigational Site
state: New South Wales
city: Maroochydore
country: Australia
facility: Pfizer Investigational Site
state: Queensland
city: Heidelberg
country: Australia
facility: Pfizer Investigational Site
city: Woodville
country: Australia
facility: Pfizer Investigational Site
city: Graz
country: Austria
facility: Pfizer Investigational Site
city: Innsbruck
country: Austria
facility: Pfizer Investigational Site
city: Duffel
country: Belgium
facility: Pfizer Investigational Site
city: Helsinki
country: Finland
facility: Pfizer Investigational Site
city: Turku
country: Finland
facility: Pfizer Investigational Site
city: Lyon
country: France
facility: Pfizer Investigational Site
state: Cedex
city: Paris
country: France
facility: Pfizer Investigational Site
state: Cedex
city: Tours
country: France
facility: Pfizer Investigational Site
state: Cedex
city: Dijon
country: France
facility: Pfizer Investigational Site
city: Paris Cedex 13
country: France
facility: Pfizer Investigational Site
city: Roubaix
country: France
facility: Pfizer Investigational Site
city: Erlangen
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: Moenchengladbach
country: Germany
facility: Pfizer Investigational Site
city: Muenster
country: Germany
facility: Pfizer Investigational Site
city: Munich
country: Germany
facility: Pfizer Investigational Site
city: Firenze
country: Italy
facility: Pfizer Investigational Site
city: Pavia
country: Italy
facility: Pfizer Investigational Site
city: Perugia
country: Italy
facility: Pfizer Investigational Site
city: Pisa
country: Italy
facility: Pfizer Investigational Site
city: Heemstede
country: Netherlands
facility: Pfizer Investigational Site
city: Heeze
country: Netherlands
facility: Pfizer Investigational Site
city: Parow
country: South Africa
facility: Pfizer Investigational Site
state: Cape Town
city: Durban
country: South Africa
facility: Pfizer Investigational Site
city: San Sebastian
country: Spain
facility: Pfizer Investigational Site
state: Guipuzcoa
city: Barcelona
country: Spain
facility: Pfizer Investigational Site
city: Gerona
country: Spain
facility: Pfizer Investigational Site
city: Sevilla
country: Spain
facility: Pfizer Investigational Site
city: Goteborg
country: Sweden
facility: Pfizer Investigational Site
city: Lavigny, LE
country: Switzerland
facility: Pfizer Investigational Site
city: Tschugg
country: Switzerland
facility: Pfizer Investigational Site
city: Bimingham
country: United Kingdom
facility: Pfizer Investigational Site
city: Bucks
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: Liverpool
country: United Kingdom
facility: Pfizer Investigational Site
city: York
country: United Kingdom
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: