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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00141414
First received: August 30, 2005
Last updated: December 28, 2006
Last verified: December 2006
History of Changes
  Purpose

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:

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

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00141414

  Show 25 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

No publications provided

ClinicalTrials.gov 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
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pregabalin
Analgesics
 Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants

ClinicalTrials.gov processed this record on May 21, 2013