Evaluation of Long-Term Safety and Efficacy of Pregabalin in Patients With Partial Seizures.

Seizure Disorder, Partial Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00150293
• Other study ID #: 1008-114
• Status: Completed
• Phase: Phase 3
• First received: September 6, 2005
• Last updated: March 4, 2015
• Start date: March 2002
• Est. completion date: November 2005

Study information

• Verified date: March 2015
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

To determine long-term safety and efficacy of pregabalin in patients with partial seizures.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 337
• Est. completion date: November 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Epilepsies, Partial
• Epilepsy
• Seizure Disorder, Partial
• Seizures

Intervention

Drug:
• Pregabalin

Locations

Country	Name	City	State
Australia	Pfizer Investigational Site	Cairns	Queensland
Australia	Pfizer Investigational Site	Camperdown	New South Wales
Australia	Pfizer Investigational Site	Chastwood	New South Wales
Australia	Pfizer Investigational Site	Deakin	Australian Capital Territory
Australia	Pfizer Investigational Site	Footscray	Victoria
Australia	Pfizer Investigational Site	Maroochydore	Queensland
Australia	Pfizer Investigational Site	Parkville	Victoria
Australia	Pfizer Investigational Site	Perth	Western Australia
Austria	Pfizer Investigational Site	Auenbruggerplatz 22
Austria	Pfizer Investigational Site	Graz
Austria	Pfizer Investigational Site	Innsbruck
Austria	Pfizer Investigational Site	Linz
Austria	Pfizer Investigational Site	Unknown
Austria	Pfizer Investigational Site	Wien
Belgium	Pfizer Investigational Site	Leuven
Canada	Pfizer Investigational Site	Barrie	Ontario
Canada	Pfizer Investigational Site	Calgary	Alberta
Canada	Pfizer Investigational Site	Edmonton	Alberta
Canada	Pfizer Investigational Site	Halifax	Nova Scotia
Canada	Pfizer Investigational Site	London	Ontario
Canada	Pfizer Investigational Site	Montreal	Quebec
Canada	Pfizer Investigational Site	Montreal	Quebec
Canada	Pfizer Investigational Site	Montreal	Quebec
Canada	Pfizer Investigational Site	Ottawa	Ontario
Canada	Pfizer Investigational Site	Penticton	British Columbia
Canada	Pfizer Investigational Site	Quebec
Canada	Pfizer Investigational Site	Regina	Saskatchewan
Canada	Pfizer Investigational Site	Saskatoon	Saskatchewan
Canada	Pfizer Investigational Site	Toronto	Ontario
Canada	Pfizer Investigational Site	Vancouver	British Columbia
Canada	Pfizer Investigational Site	Windsor	Ontario
Germany	Pfizer Investigational Site	Berlin
Germany	Pfizer Investigational Site	Bernau
Germany	Pfizer Investigational Site	Bonn
Germany	Pfizer Investigational Site	Dresden
Germany	Pfizer Investigational Site	Erlangen
Germany	Pfizer Investigational Site	Essen
Germany	Pfizer Investigational Site	Frankfurt
Germany	Pfizer Investigational Site	Freiburg
Germany	Pfizer Investigational Site	Goettingen
Germany	Pfizer Investigational Site	Hamburg
Germany	Pfizer Investigational Site	Mainz
Germany	Pfizer Investigational Site	Muenchen
Germany	Pfizer Investigational Site	Ulm	BW
Netherlands	Pfizer Investigational Site	AE Breda
Netherlands	Pfizer Investigational Site	Blaricum
Netherlands	Pfizer Investigational Site	Ve Heeze
Poland	Pfizer Investigational Site	Bialystok
Poland	Pfizer Investigational Site	Bydgoszcz
Poland	Pfizer Investigational Site	Choroszcz
Poland	Pfizer Investigational Site	Gdansk
Poland	Pfizer Investigational Site	Gdansk
Poland	Pfizer Investigational Site	Grudziadz
Poland	Pfizer Investigational Site	Katowice
Poland	Pfizer Investigational Site	Krakow
Poland	Pfizer Investigational Site	Lublin
Poland	Pfizer Investigational Site	Mosina
Poland	Pfizer Investigational Site	Olsztyn
Poland	Pfizer Investigational Site	Plock
Poland	Pfizer Investigational Site	Poznan
Poland	Pfizer Investigational Site	Poznan
Poland	Pfizer Investigational Site	Torun
Poland	Pfizer Investigational Site	Warsaw
Poland	Pfizer Investigational Site	Warsaw
Poland	Pfizer Investigational Site	Warszawa
Poland	Pfizer Investigational Site	Warszawa
Portugal	Pfizer Investigational Site	Coimbra
Portugal	Pfizer Investigational Site	Porto
Spain	Pfizer Investigational Site	Barcelona
Spain	Pfizer Investigational Site	Girona
Spain	Pfizer Investigational Site	Granada
Spain	Pfizer Investigational Site	Madrid
Spain	Pfizer Investigational Site	Madrid
Spain	Pfizer Investigational Site	Malaga
Spain	Pfizer Investigational Site	Zaragoza
United Kingdom	Pfizer Investigational Site	Blackpool
United Kingdom	Pfizer Investigational Site	Dundee
United Kingdom	Pfizer Investigational Site	Glasgow
United Kingdom	Pfizer Investigational Site	Leeds
United Kingdom	Pfizer Investigational Site	London
United Kingdom	Pfizer Investigational Site	Middlesborough	N. York
United Kingdom	Pfizer Investigational Site	Northampton
United Kingdom	Pfizer Investigational Site	Unknown	Glasgow
United Kingdom	Pfizer Investigational Site	Washington	Tyne & Wear
United Kingdom	Pfizer Investigational Site	Wolverhampton

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

Australia,  Austria,  Belgium,  Canada,  Germany,  Netherlands,  Poland,  Portugal,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety Efficacy