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To Evaluate Long-Term Safety and Efficacy of Pregabalin in Patients With Partial Seizures.

This study has been completed.
Information provided by:
Pfizer Identifier:
First received: August 30, 2005
Last updated: December 28, 2006
Last verified: December 2006
To evaluate long-term safety and efficacy of pregabalin in patients with partial seizures.

Condition Intervention Phase
Seizure Disorder, Partial
Drug: Pregabalin
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pregabalin Open-Label, Multicenter Add-On Trial Following a 4-Day Double-Blind Transition Period 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 Efficacy

Estimated Enrollment: 325
Study Start Date: October 1998
Estimated Study Completion Date: November 2005

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

Inclusion Criteria:

  • Must have met the inclusion criteria for preceding double-blind study
  • Have received double-blind study medication and wish to receive open-label pregabalin.

Exclusion Criteria:

  • Cannot have absence seizures
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00141245

  Show 46 Study Locations
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer
  More Information Identifier: NCT00141245     History of Changes
Other Study ID Numbers: 1008-012 
Study First Received: August 30, 2005
Last Updated: December 28, 2006
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Epilepsies, 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 processed this record on October 21, 2016