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

Seizure Disorder, Partial Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00141245
• Other study ID #: 1008-012
• Status: Completed
• Phase: Phase 3
• First received: August 30, 2005
• Last updated: December 28, 2006
• Start date: October 1998
• Est. completion date: November 2005

Study information

• Verified date: December 2006
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 325
• 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 have absence seizures

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	Chatswood	New South Wales
Australia	Pfizer Investigational Site	Deakin	Australian Capital Territory
Australia	Pfizer Investigational Site	Heidelberg
Australia	Pfizer Investigational Site	Maroochydore	Queensland
Australia	Pfizer Investigational Site	Westmead	New South Wales
Australia	Pfizer Investigational Site	Woodville
Austria	Pfizer Investigational Site	Graz
Austria	Pfizer Investigational Site	Innsbruck
Belgium	Pfizer Investigational Site	Duffel
Finland	Pfizer Investigational Site	Helsinki
Finland	Pfizer Investigational Site	Turku
France	Pfizer Investigational Site	Dijon
France	Pfizer Investigational Site	Lyon	Cedex
France	Pfizer Investigational Site	Paris	Cedex
France	Pfizer Investigational Site	Paris Cedex 13
France	Pfizer Investigational Site	Roubaix
France	Pfizer Investigational Site	Tours	Cedex
Germany	Pfizer Investigational Site	Erlangen
Germany	Pfizer Investigational Site	Freiburg
Germany	Pfizer Investigational Site	Goettingen
Germany	Pfizer Investigational Site	Hamburg
Germany	Pfizer Investigational Site	Mainz
Germany	Pfizer Investigational Site	Moenchengladbach
Germany	Pfizer Investigational Site	Muenster
Germany	Pfizer Investigational Site	Munich
Italy	Pfizer Investigational Site	Firenze
Italy	Pfizer Investigational Site	Pavia
Italy	Pfizer Investigational Site	Perugia
Italy	Pfizer Investigational Site	Pisa
Netherlands	Pfizer Investigational Site	Heemstede
Netherlands	Pfizer Investigational Site	Heeze
South Africa	Pfizer Investigational Site	Durban
South Africa	Pfizer Investigational Site	Parow	Cape Town
Spain	Pfizer Investigational Site	Barcelona
Spain	Pfizer Investigational Site	Gerona
Spain	Pfizer Investigational Site	San Sebastian	Guipuzcoa
Spain	Pfizer Investigational Site	Sevilla
Sweden	Pfizer Investigational Site	Goteborg
Switzerland	Pfizer Investigational Site	Lavigny, LE
Switzerland	Pfizer Investigational Site	Tschugg
United Kingdom	Pfizer Investigational Site	Bimingham
United Kingdom	Pfizer Investigational Site	Bucks
United Kingdom	Pfizer Investigational Site	Dundee
United Kingdom	Pfizer Investigational Site	Glasgow
United Kingdom	Pfizer Investigational Site	Liverpool
United Kingdom	Pfizer Investigational Site	York

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

Australia,  Austria,  Belgium,  Finland,  France,  Germany,  Italy,  Netherlands,  South Africa,  Spain,  Sweden,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety Efficacy