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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00143143
Other study ID # 1008-000-164
Secondary ID
Status Completed
Phase Phase 3
First received August 30, 2005
Last updated July 21, 2006
Start date September 2001
Est. completion date February 2006

Study information

Verified date March 2006
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The primary purpose of the protocol is to evaluate the long-term safety of pregabalin in patients with partial seizures.


Recruitment information / eligibility

Status Completed
Enrollment 300
Est. completion date February 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients must have met the inclusion criteria for Study 1008-157, have received double-blind study medication, and wish to receive open-label pregabalin

- Have the diagnosis of epilepsy with partial seizures and have a minimum of 4 partial seizures during the 6 weeks prior to screening

- Be currently taking 1 to 3 AEDs.

Exclusion Criteria:

- Have a treatable cause of seizures

- Experienced a serious adverse event during Study 1008-157 which was determined to be possibly related to study medication

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


Intervention

Drug:
Pregabalin


Locations

Country Name City State
Austria Pfizer Investigational Site Innsbruck
Austria Pfizer Investigational Site Mauer Bei Amstetten
Austria Pfizer Investigational Site St Polten
Austria Pfizer Investigational Site Wien
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 Ottawa Ontario
Canada Pfizer Investigational Site Trois Rivieres Quebec
Canada Pfizer Investigational Site Vancouver British Columbia
France Pfizer Investigational Site Colomiers
France Pfizer Investigational Site Dommartin Les Toul
France Pfizer Investigational Site Lille Cedex
France Pfizer Investigational Site Marseille Cedex 05
France Pfizer Investigational Site Marseille Cedex 09
France Pfizer Investigational Site Montpellier Cedex 5
France Pfizer Investigational Site Paris Cedex 13
France Pfizer Investigational Site Rennes Cedex
France Pfizer Investigational Site Strasbourg
Germany Pfizer Investigational Site Berlin
Germany Pfizer Investigational Site Berlin
Germany Pfizer Investigational Site Bielefeld
Germany Pfizer Investigational Site Bonn
Germany Pfizer Investigational Site Essen
Germany Pfizer Investigational Site Frankfurt
Germany Pfizer Investigational Site Freiburg
Germany Pfizer Investigational Site Goettingen
Germany Pfizer Investigational Site Kehl
Germany Pfizer Investigational Site Marburg
Germany Pfizer Investigational Site ULM
Italy Pfizer Investigational Site Firenze
Italy Pfizer Investigational Site Perugia
Italy Pfizer Investigational Site Pisa
Italy Pfizer Investigational Site Siena
Italy Pfizer Investigational Site Unknown
Lithuania Pfizer Investigational Site Vilnius
Lithuania Pfizer Investigational Site Vilnius
Spain Pfizer Investigational Site Barcelona
Spain Pfizer Investigational Site Donostia-San Sebastian
Spain Pfizer Investigational Site Gerona
Spain Pfizer Investigational Site Madrid
Spain Pfizer Investigational Site Madrid
United Kingdom Pfizer Investigational Site Fazakerley, Liverpool
United Kingdom Pfizer Investigational Site Glascow Scotland
United Kingdom Pfizer Investigational Site York

Sponsors (1)

Lead Sponsor Collaborator
Pfizer

Countries where clinical trial is conducted

Austria,  Canada,  France,  Germany,  Italy,  Lithuania,  Spain,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Safety assessments are performed at quarterly visits up until the study is closed.
Secondary Seizure frequency is assessed throughout the study until the study is closed.
See also
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