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Completed

NCT Number: NCT00143143

Pregabalin Open-Label Extension Trial in Patients With Partial Seizures

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

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Key information

Conditions

Epilepsies, Partial Brain Diseases Central Nervous System Diseases Epilepsy Epilepsy, Complex 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, Innsbruck, Austria

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Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Pregabalin

Drug

Primary outcomes

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

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

Pregabalin BID Open-Label Add-On Trial: A Follow-Up Study To Determine Long-Term Safety and Efficacy in Patients With Partial Seizures

Important dates

Study start
2001
Study completion
2006
First posted
Sep 2, 2005
Registry last updated
Jul 24, 2006

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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