To Evaluate the Long-Term Safety of Pregabalin in Refractory Partial Epilepsy.

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 of pregabalin in refractory partial epilepsy.

Condition Intervention Phase
Epilepsy, Partial
Drug: Pregabalin
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pregabablin Open-Label, Follow-On Safety Trial In Patients With Refractory Partial Epilepsy.

Resource links provided by NLM:

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Safety

Estimated Enrollment: 82
Study Start Date: November 1997
Estimated Study Completion Date: October 2005

Ages Eligible for Study:   18 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:

  • Pregnant or considering becoming pregnant.
  • Receiving any concomitant medication that could alter the effectiveness of their medication response or seizure frequency.
  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: NCT00141414

  Show 25 Study Locations
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer
  More Information

No publications provided Identifier: NCT00141414     History of Changes
Other Study ID Numbers: 1008-008
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
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 November 24, 2015