Pregabalin Open-Label Extension Trial in Patients With Partial Seizures

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00143143
Recruitment Status : Completed
First Posted : September 2, 2005
Last Update Posted : July 24, 2006
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Brief Summary:
The primary purpose of the protocol is to evaluate the long-term safety of pregabalin in patients with partial seizures.

Condition or disease Intervention/treatment Phase
Epilepsies, Partial Epilepsy, Complex Partial Drug: Pregabalin Phase 3

Study Type : Interventional  (Clinical Trial)
Enrollment : 300 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pregabalin BID Open-Label Add-On Trial: A Follow-Up Study To Determine Long-Term Safety and Efficacy in Patients With Partial Seizures
Study Start Date : September 2001
Study Completion Date : February 2006

Primary Outcome Measures :
  1. Safety assessments are performed at quarterly visits up until the study is closed.

Secondary Outcome Measures :
  1. Seizure frequency is assessed throughout the study until the study is closed.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00143143

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Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer Identifier: NCT00143143     History of Changes
Other Study ID Numbers: 1008-000-164
First Posted: September 2, 2005    Key Record Dates
Last Update Posted: July 24, 2006
Last Verified: March 2006

Additional relevant MeSH terms:
Epilepsies, Partial
Epilepsy, Complex Partial
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs