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Completed

NCT Number: NCT00596466

Extension Study Of Long-Term Safety And Efficacy Of Pregabalin As Monotherapy (Lyrica) In Patients With Partial Seizures

This study will evaluate the long term safety and efficacy of pregabalin (Lyrica) when administered by itself (without any other anti-epileptic medication) to epilepsy patients for the treatment of partial seizures. This is an extension study to a previous clinical trial.

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Key information

Conditions

Epilepsy Brain Diseases Central Nervous System Diseases Epilepsies, Partial Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Pfizer Investigational Site, Beroun, Czechia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Completed the previous protocol and wish to continue to receive pregabalin.
  • Diagnosis of epilepsy with partial seizures

Exclusion criteria

  • Early withdrawal from the previous protocol, an episode of status epliepticus, or primary generalized epilepsy.

Treatment and study plan

Pregabalin

Drug

pregabalin

Primary outcomes

  1. Seizure Frequency

    Time frame: Baseline up to Week 28

  2. Number of Participants With (All Causality) Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Time frame: Baseline up to Week 28

    Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Participants with multiple occurrences of an AE within a category were counted once within the category.

  3. Number of Participants With Laboratory Test Values of Potential Clinical Importance

    Time frame: Baseline up to Week 28

    Pre-defined criteria were established for each laboratory test (hematology, blood chemistry and urinalysis) to define the values that would be identified as of potential clinical importance.

Sponsors and collaborators

Lead sponsor

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

Industry

Registry information

Official study title

An Open-Label Multicenter Extension Study To Determine Long Term Safety And Efficacy Of Pregabalin (Lyrica) As Monotherapy In Patients With Partial Seizures

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Jan 17, 2008
Registry last updated
Jan 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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