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: November 5, 2009
Last verified: November 2009
To evaluate the 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 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 Efficacy

Enrollment: 455
Study Start Date: July 1998
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 the 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
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Please refer to this study by its identifier: NCT00141388

  Show 56 Study Locations
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer
  More Information

No publications provided Identifier: NCT00141388     History of Changes
Other Study ID Numbers: 1008-010
Study First Received: August 30, 2005
Last Updated: November 5, 2009
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 November 24, 2015