Clinical trial NCT00141427: Pregabalin In Partial Seizures: An Open-Label, International, Multicenter Add-On Therapy Trial.
Official title: Pregabalin In Partial Seizures (Preps) : An Open-Label, International, Multicenter Add-On Therapy Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Seizures
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-01
Enrollment: 540
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 assess the clinical improvement (change in seizure frequency), safety and tolerability of patients with partial seizures following adjunctive therapy of pregabalin BID in addition to existing standard AEDs.


Eligibility criteria: Inclusion Criteria:

* Male and female subjects with a diagnosis of partial epilepsy.
* 18 years and older.

Exclusion Criteria:

* Having a treatable cause of seizure.
* Having a progressive neurological or systemic disorder

Primary outcomes:
measure: Reduction in seizure frequency.
Secondary outcomes:
Other outcomes:
Locations:
city: Brugge
country: Belgium
facility: Pfizer Investigational Site
city: Brussels
country: Belgium
facility: Pfizer Investigational Site
city: Duffel
country: Belgium
facility: Pfizer Investigational Site
city: Gent
country: Belgium
facility: Pfizer Investigational Site
city: Leuven
country: Belgium
facility: Pfizer Investigational Site
city: Liege
country: Belgium
facility: Pfizer Investigational Site
city: Tielt
country: Belgium
facility: Pfizer Investigational Site
city: Yvoir
country: Belgium
facility: Pfizer Investigational Site
city: Helsinki
country: Finland
facility: Pfizer Investigational Site
city: Kuopio
country: Finland
facility: Pfizer Investigational Site
city: Tampere
country: Finland
facility: Pfizer Investigational Site
city: Marseille
country: France
facility: Pfizer Investigational Site
state: Cedex 05
city: Montpellier
country: France
facility: Pfizer Investigational Site
state: Cedex 5
city: Lyon
country: France
facility: Pfizer Investigational Site
state: Cedex
city: Bayonne
country: France
facility: Pfizer Investigational Site
city: Bordeaux Cedex
country: France
facility: Pfizer Investigational Site
city: Grenoble Cedex
country: France
facility: Pfizer Investigational Site
city: Lille Cedex
country: France
facility: Pfizer Investigational Site
city: Marseille
country: France
facility: Pfizer Investigational Site
city: Nancy
country: France
facility: Pfizer Investigational Site
city: Nice Cedex
country: France
facility: Pfizer Investigational Site
city: Paris
country: France
facility: Pfizer Investigational Site
city: Paris
country: France
facility: Pfizer Investigational Site
city: Paris
country: France
facility: Pfizer Investigational Site
city: Rennes
country: France
facility: Pfizer Investigational Site
city: Strasbourg
country: France
facility: Pfizer Investigational Site
city: Toulouse
country: France
facility: Pfizer Investigational Site
city: Tours
country: France
facility: Pfizer Investigational Site
city: Den Haag
country: Netherlands
facility: Pfizer Investigational Site
state: ZH
city: Alkmaar
country: Netherlands
facility: Pfizer Investigational Site
city: Breda
country: Netherlands
facility: Pfizer Investigational Site
city: Heeze
country: Netherlands
facility: Pfizer Investigational Site
city: Hilversum
country: Netherlands
facility: Pfizer Investigational Site
city: Oss
country: Netherlands
facility: Pfizer Investigational Site
city: Southwest Heemstede
country: Netherlands
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: Warszawa
country: Poland
facility: Pfizer Investigational Site
city: Warszawa
country: Poland
facility: Pfizer Investigational Site
city: Warszawa
country: Poland
facility: Pfizer Investigational Site
city: Wroclaw
country: Poland
facility: Pfizer Investigational Site
city: Braga
country: Portugal
facility: Pfizer Investigational Site
city: Funchal
country: Portugal
facility: Pfizer Investigational Site
city: Lisboa
country: Portugal
facility: Pfizer Investigational Site
city: Matosinhos
country: Portugal
facility: Pfizer Investigational Site
city: Ponta Delgada
country: Portugal
facility: Pfizer Investigational Site
city: Porto
country: Portugal
facility: Pfizer Investigational Site
city: Lausanne
country: Switzerland
facility: Pfizer Investigational Site
city: Zurich
country: Switzerland
facility: Pfizer Investigational Site
city: Zurich
country: Switzerland
facility: Pfizer Investigational Site
city: Cambridge
country: United Kingdom
facility: Pfizer Investigational Site
state: Cambs
city: Truro
country: United Kingdom
facility: Pfizer Investigational Site
state: Cornwall
city: Plymouth
country: United Kingdom
facility: Pfizer Investigational Site
state: Devon
city: Glasgow
country: United Kingdom
facility: Pfizer Investigational Site
city: Oxford
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: