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Pregabalin Epilepsy Add-On Trial

This study has been completed.
Information provided by:
Pfizer Identifier:
First received: August 30, 2005
Last updated: April 28, 2009
Last verified: April 2009
To evaluate the efficacy of pregabalin as adjunctive therapy, using a flexible, optimized dose schedule with dose adjustment based on clinical response and tolerability, compared to placebo in subjects with partial seizures

Condition Intervention Phase
Partial Seizures Drug: pregabalin Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Pregabalin Add-On Titration Trial: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Efficacy and Safety of Pregabalin (150 mg - 600 mg/Day) Using a Flexible, Optimized Dose Schedule in Subjects With Partial Seizures

Resource links provided by NLM:

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Response ratio (RRatio or symmetrized percent change) for all partial seizures

Secondary Outcome Measures:
  • Responder rate, Percent change, Percent of SGTC responders, Seizure freedom measures, Change in number of seizure-free days (SFD) per a 28-day period, Analysis by seizure type, HADS, Weekly and endpoint mean sleep interference scores from DSIS, QOLIE-31

Enrollment: 178
Study Start Date: October 2005
Study Completion Date: August 2006

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Have a diagnosis of epilepsy with partial seizures (as defined in the ILAE Classification of Seizures) and be currently taking 1-3 AEDs
  • Have a minimum of 4 partial seizures occurring over at least 2 days during the 6-week baseline with no 28-day period free of partial seizures

Exclusion Criteria:

  • Have a treatable cause of seizures
  • Are currently receiving treatment with CNS-active compounds (exception: single antidepressant, hypnotics, and standard AEDs), vigabatrin, Felbatol (felbamate), Neurontin (gabapentin)
  Contacts and Locations
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Please refer to this study by its identifier: NCT00141258

Korea, Republic of
Pfizer Investigational Site
Daegu, Korea, Republic of
Pfizer Investigational Site
Daejeon, Korea, Republic of
Pfizer Investigational Site
Gwangju, Korea, Republic of
Pfizer Investigational Site
Incheon, Korea, Republic of
Pfizer Investigational Site
Seoul, Korea, Republic of
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc. Identifier: NCT00141258     History of Changes
Other Study ID Numbers: A0081079
Study First Received: August 30, 2005
Last Updated: April 28, 2009

Additional relevant MeSH terms:
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs processed this record on August 22, 2017