Clinical trial NCT00143130: Pregabalin In Partial Seizures Extension Study
Official title: Pregabalin in Partial Seizures (PREPS) Extension Study: An 18-month Follow-on Open-label, International, Multicenter Add-on Therapy Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Seizures
Keywords: phase 4, open label, seizures, epilepsy, add-on therapy, pregabalin, lyrica
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-02
Enrollment: 227
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 efficacy and safety of pregabalin (150 to 600mg/day) as adjunctive treatment in patients with partial seizures.


Eligibility criteria: Inclusion Criteria:

* met the inclusion/exclusion criteria for A0081005
* have completed the 21-week study and have shown a significant clinical response and wish to continue treatment

Exclusion Criteria:

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

Primary outcomes:
measure: Reduction in seizure frequency.
timeFrame: 18 months
Secondary outcomes:
measure: Seizure-free patients during each 3-month period
timeFrame: 18 Months
measure: Responder Rate 50% during each 3-month period (proportion of patients with 50% or greater reduction of seizures).
timeFrame: 18 Months
measure: Responder rate 75% during each 3-month period (proportion of patients with 75% or greater reduction of seizures).
timeFrame: 18 Months
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: Paris
country: France
facility: Pfizer Investigational Site
state: Cedex 14
city: Lille
country: France
facility: Pfizer Investigational Site
state: Cedex
city: Lyon
country: France
facility: Pfizer Investigational Site
state: Cedex
city: Marsille
country: France
facility: Pfizer Investigational Site
state: Cedex
city: Rennes
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: Marseille 13
country: France
facility: Pfizer Investigational Site
city: Montpellier Cedex 5
country: France
facility: Pfizer Investigational Site
city: Nancy
country: France
facility: Pfizer Investigational Site
city: Nice
country: France
facility: Pfizer Investigational Site
city: Paris Cedex 13
country: France
facility: Pfizer Investigational Site
city: Paris Cedex 14
country: France
facility: Pfizer Investigational Site
city: Paris
country: France
facility: Pfizer Investigational Site
city: Strasbourg
country: France
facility: Pfizer Investigational Site
city: Toulouse
country: France
facility: Pfizer Investigational Site
city: Tours Cedex
country: France
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: Coimbra
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: 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
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: