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COMPLETEDPHASE4

Lyrica (Pregabalin) Administered as an Add-on Therapy for Partial Seizures (LEADER).

Lyrica (Pregabalin) Administered As An Add-On Therapy For Partial Seizures (LEADER) An Open-Label, Multicenter Add-On Therapy Trial

NCT00288639•Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

View on ClinicalTrials.gov

Summary

The objective of study is to assess the clinical improvement (change in seizure frequency), safety, and tolerability of subjects with partial seizures following adjunctive therapy of pregabalin BID (150 to 600 mg/day titration) in addition to existing standards AEDs.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Outpatients equal to or greater than 18 years of age with diagnosis of epilepsy with partial seizures having minimum of two partial seizures during a two month period before the baseline visit
•Having a clinical history of epilepsy and AED treatment at least 1 year prior to inclusion

Exclusion Criteria

•AED or Seizures/Epilepsy Related Exclusions:having a treatable cause of seizures
•Having absences seizures
•Having had status epileptics within the year prior to inclusion
•Having a progressive neurological or systematic disorder
•Having known significant renal or hepatic dysfunction

Locations (8)

Pfizer Investigational Site

Athens, Greece

Pfizer Investigational Site

Athens, Greece

Pfizer Investigational Site

Heraklio, Greece

Pfizer Investigational Site

Mesogion, Athen, Greece

Pfizer Investigational Site

Pátrai, Greece

Pfizer Investigational Site

Thessaloniki, Greece

Pfizer Investigational Site

Thessaloniki, Greece

Pfizer Investigational Site

Thessaloniki, Greece

Key Dates

Start Date

December 1, 2005

Primary Completion Date

December 1, 2007

Completion Date

December 1, 2007

Last Updated

January 22, 2021

Enrollment

ACTUAL participants

Conditions

Epilepsy

Interventions

Pregabalin

DRUG

Thalamus Seizure Detection With a Deep Brain Stimulator System

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Epilepsy; Seizure

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RECRUITINGPHASE1

Investigation of Blood-Brain-Barrier Breakdown Using Manganese Magnetic Resonance Imaging in Drug-Resistant Epilepsy

NCT02531880

Epilepsy

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RECRUITINGNA

Intracranial Investigation of Neural Circuity Underlying Human Mood

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 22, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Lyrica (Pregabalin) Administered as an Add-on Therapy for Partial Seizures (LEADER).

Inclusion Criteria

Exclusion Criteria

Thalamus Seizure Detection With a Deep Brain Stimulator System

Investigation of Blood-Brain-Barrier Breakdown Using Manganese Magnetic Resonance Imaging in Drug-Resistant Epilepsy

Intracranial Investigation of Neural Circuity Underlying Human Mood

Late-Onset Seizures: Trial of Vascular Risk Investigation and Treatment

AI-Based Mobile Intervention on Medication Non-Adherence and Transition

MEHMO Natural History and Biomarkers