To Evaluate the 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 the long-term safety and tolerability 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 BID Open-Label Add-On Trial: An Open-Label, Multicenter Follow-On 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 Tolerability

Estimated Enrollment: 750
Study Start Date: November 1999
Estimated Study Completion Date: July 2005

Ages Eligible for Study:   12 Years and older
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: NCT00141336

  Show 103 Study Locations
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer
  More Information

No publications provided Identifier: NCT00141336     History of Changes
Other Study ID Numbers: 1008-035
Study First Received: August 30, 2005
Last Updated: December 28, 2006
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Epilepsies, Partial
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Calcium Channel Blockers
Cardiovascular Agents
Central Nervous System Agents
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses processed this record on October 07, 2015