Extension Study Of Long-Term Safety And Efficacy Of Pregabalin As Monotherapy (Lyrica) 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: NCT00596466
Recruitment Status : Completed
First Posted : January 17, 2008
Results First Posted : September 11, 2012
Last Update Posted : September 11, 2012
Information provided by (Responsible Party):

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Epilepsy Drug: pregabalin Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Multicenter Extension Study To Determine Long Term Safety And Efficacy Of Pregabalin (Lyrica) As Monotherapy In Patients With Partial Seizures
Study Start Date : April 2008
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy Seizures
Drug Information available for: Pregabalin
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1 Drug: pregabalin

Primary Outcome Measures :
  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.

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:

  • 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.

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): NCT00596466

  Show 44 Study Locations
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer

Additional Information:
Responsible Party: Pfizer Identifier: NCT00596466     History of Changes
Other Study ID Numbers: A0081160
First Posted: January 17, 2008    Key Record Dates
Results First Posted: September 11, 2012
Last Update Posted: September 11, 2012
Last Verified: August 2012

Keywords provided by Pfizer:
extension study
partial epilepsy

Additional relevant MeSH terms:
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