Pregabalin Epilepsy Add-On Trial - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00141258

Purpose

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 Seizure With or Without Secondary Generalization	Drug: pregabalin	Phase III

Genetics Home Reference related topics: pyridoxal 5'-phosphate-dependent epilepsy pyridoxine-dependent epilepsy

MedlinePlus related topics: Epilepsy Seizures

Drug Information available for: Pregabalin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

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

Estimated Enrollment:	177
Study Start Date:	October 2005
Estimated Study Completion Date:	August 2007

Eligibility

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

Criteria

Inclusion Criteria:

Have a diagnosis of epilepsy with partial seizures (as defined in the ILAE Clssification of Seizures) and be currently taking 1-3 AEDs
Have a minimum of 4 partial seizures ocurring 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00141258

Locations

Korea, Republic of
Pfizer Investigational Site
Seoul, Korea, Republic of
Pfizer Investigational Site
Incheon, Korea, Republic of
Pfizer Investigational Site
Daejeon, Korea, Republic of
Pfizer Investigational Site
Gwangju, Korea, Republic of
Pfizer Investigational Site
Daegu, Korea, Republic of

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Link to ClinicalStudyResults.org Posting This link exits the ClinicalTrials.gov site

Study ID Numbers:	A0081079
Study First Received:	August 30, 2005
Last Updated:	August 28, 2007
ClinicalTrials.gov Identifier:	NCT00141258
Health Authority:	South Korea: Korea Food and Drug Administration (KFDA)

Study placed in the following topic categories:

Signs and Symptoms
Epilepsy
Seizures
Neoplasm Metastasis

Pregabalin
Neurologic Manifestations
Central Nervous System Diseases
Brain Diseases

Additional relevant MeSH terms:

Sensory System Agents
Therapeutic Uses
Physiological Effects of Drugs
Nervous System Diseases
Peripheral Nervous System Agents

Analgesics
Central Nervous System Agents
Anticonvulsants
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 13, 2009