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NCT00143130 Clinical Trial

Pregabalin In Partial Seizures Extension Study

Seizures Clinical Trial

— PREPS EXT  

Official title:
Pregabalin in Partial Seizures (PREPS) Extension Study: An 18-month Follow-on Open-label, International, Multicenter Add-on Therapy Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00143130
Other study ID # A0081015
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date April 2005
Est. completion date September 2007

Study information
Verified date March 2015
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To evaluate long-term efficacy and safety of pregabalin (150 to 600mg/day) as adjunctive treatment in patients with partial seizures.

Recruitment information / eligibility
Status Completed
Enrollment 227
Est. completion date September 2007
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Pregabalin
Pregabalin

Locations
Country Name City State
Belgium Pfizer Investigational Site Brugge
Belgium Pfizer Investigational Site Brussels
Belgium Pfizer Investigational Site Duffel
Belgium Pfizer Investigational Site Gent
Belgium Pfizer Investigational Site Leuven
Belgium Pfizer Investigational Site Liege
Belgium Pfizer Investigational Site Tielt
Belgium Pfizer Investigational Site Yvoir
Finland Pfizer Investigational Site Helsinki
Finland Pfizer Investigational Site Kuopio
Finland Pfizer Investigational Site Tampere
France Pfizer Investigational Site Bayonne
France Pfizer Investigational Site Bordeaux Cedex
France Pfizer Investigational Site Grenoble Cedex
France Pfizer Investigational Site Lille Cedex
France Pfizer Investigational Site Lyon Cedex
France Pfizer Investigational Site Marseille 13
France Pfizer Investigational Site Marsille Cedex
France Pfizer Investigational Site Montpellier Cedex 5
France Pfizer Investigational Site Nancy
France Pfizer Investigational Site Nice
France Pfizer Investigational Site Paris Cedex 14
France Pfizer Investigational Site Paris
France Pfizer Investigational Site Paris Cedex 13
France Pfizer Investigational Site Paris Cedex 14
France Pfizer Investigational Site Rennes Cedex
France Pfizer Investigational Site Strasbourg
France Pfizer Investigational Site Toulouse
France Pfizer Investigational Site Tours Cedex
Poland Pfizer Investigational Site Katowice
Poland Pfizer Investigational Site Krakow
Poland Pfizer Investigational Site Lublin
Poland Pfizer Investigational Site Warszawa
Poland Pfizer Investigational Site Warszawa
Poland Pfizer Investigational Site Warszawa
Poland Pfizer Investigational Site Wroclaw
Portugal Pfizer Investigational Site Braga
Portugal Pfizer Investigational Site Coimbra
Portugal Pfizer Investigational Site Funchal
Portugal Pfizer Investigational Site Lisboa
Portugal Pfizer Investigational Site Matosinhos
Portugal Pfizer Investigational Site Ponta Delgada
Portugal Pfizer Investigational Site Ponta Delgada
Portugal Pfizer Investigational Site Porto
Switzerland Pfizer Investigational Site Lausanne
Switzerland Pfizer Investigational Site Zurich
Switzerland Pfizer Investigational Site Zurich

Sponsors (1)
Lead Sponsor Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Countries where clinical trial is conducted

Belgium,  Finland,  France,  Poland,  Portugal,  Switzerland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Reduction in seizure frequency. 18 months
Secondary Seizure-free patients during each 3-month period 18 Months
Secondary Responder Rate 50% during each 3-month period (proportion of patients with 50% or greater reduction of seizures). 18 Months
Secondary Responder rate 75% during each 3-month period (proportion of patients with 75% or greater reduction of seizures). 18 Months
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