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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00141245
First received: August 30, 2005
Last updated: December 28, 2006
Last verified: December 2006
History of Changes
  Purpose

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:

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

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
  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:

  • Cannot have absence seizures
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00141245

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

No publications provided

ClinicalTrials.gov 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:
Epilepsy
Epilepsies, Partial
Seizures
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
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants

ClinicalTrials.gov processed this record on May 16, 2013