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Pregabalin Open-Label Extension Trial in Patients With Partial Seizures

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00143143
First Posted: September 2, 2005
Last Update Posted: July 24, 2006
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.
Information provided by:
Pfizer
  Purpose
The primary purpose of the protocol is to evaluate the long-term safety of pregabalin in patients with partial seizures.

Condition Intervention Phase
Epilepsies, Partial Epilepsy, Complex Partial Drug: Pregabalin Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

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

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

Estimated Enrollment: 300
Study Start Date: September 2001
Estimated Study Completion Date: February 2006
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00143143


  Show 46 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

ClinicalTrials.gov Identifier: NCT00143143     History of Changes
Other Study ID Numbers: 1008-000-164
First Submitted: August 30, 2005
First Posted: September 2, 2005
Last Update Posted: July 24, 2006
Last Verified: March 2006

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