Pregabalin Open-Label Extension Trial in Patients With Partial Seizures

Pfizer300 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

300

Conditions

Epilepsies, Partial Epilepsy, Complex Partial

Interventions

PregabalinDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (47)

Outcomes

Primary Outcomes

Safety assessments are performed at quarterly visits up until the study is closed.

Secondary Outcomes

Seizure frequency is assessed throughout the study until the study is closed.

Data from ClinicalTrials.gov

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Pfizer Investigational Site

Innsbruck, Austria

Pfizer Investigational Site

Mauer bei Amstetten, Austria

Pfizer Investigational Site

Sankt Pölten, Austria

Pfizer Investigational Site

Vienna, Austria

Pfizer Investigational Site

Calgary, Alberta, Canada

Pfizer Investigational Site

Edmonton, Alberta, Canada

Pfizer Investigational Site

Vancouver, British Columbia, Canada

Pfizer Investigational Site

Halifax, Nova Scotia, Canada

Pfizer Investigational Site

Barrie, Ontario, Canada

Pfizer Investigational Site

London, Ontario, Canada

...and 37 more locations