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| Sponsor: | Pfizer |
|---|---|
| Information provided by: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT00537940 |
Purpose
To compare the efficacy of pregabalin and gabapentin, as adjunctive therapy in subjects with partial seizures.
| Condition | Intervention | Phase |
|---|---|---|
|
Epilepsy Partial Seizure Disorder Epilepsies, Partial Complex Partial Seizure Disorder |
Drug: Pregabalin Drug: Gabapentin |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Randomized, Double-Blind, Parallel-Group, Multi-Center, Comparative, Flexible Dose Trial Of Pregabalin Versus Gabapentin As Adjunctive Therapy In Subjects With Partial Seizures |
| Estimated Enrollment: | 520 |
| Study Start Date: | February 2008 |
| Estimated Study Completion Date: | May 2011 |
| Estimated Primary Completion Date: | May 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| A: Active Comparator |
Drug: Pregabalin
150, 300, 450 mg/day administered orally TID, until seizure control/improvement or intolerable side effects
|
| B: Active Comparator |
Drug: Gabapentin
300, 600, 1200, 2000 mg/day administered orally TID, until seizure control/improvement or intolerable side effects
|
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Pfizer CT.gov Call Center | 1-800-718-1021 |
Show 55 Study Locations| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
| Responsible Party: | Pfizer, Inc. ( Director, Clinical Trials Disclosure Group ) |
| Study ID Numbers: | A0081143 |
| Study First Received: | September 28, 2007 |
| Last Updated: | February 8, 2010 |
| ClinicalTrials.gov Identifier: | NCT00537940 History of Changes |
| Health Authority: | Spain: Agencia Española del Medicamento y Productos Sanitarios |
|
Epilepsies, Partial Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Gabapentin Anti-Dyskinesia Agents Physiological Effects of Drugs Psychotropic Drugs Antiparkinson Agents Calcium Channel Blockers Excitatory Amino Acid Agents Brain Diseases Epilepsy, Complex Partial Membrane Transport Modulators Signs and Symptoms Pathologic Processes |
Sensory System Agents Therapeutic Uses Analgesics Excitatory Amino Acid Antagonists Tranquilizing Agents Disease Nervous System Diseases Seizures Central Nervous System Depressants Pregabalin Central Nervous System Diseases Cardiovascular Agents Antimanic Agents Pharmacologic Actions Epilepsy |