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| Sponsor: | Pfizer |
|---|---|
| Information provided by (Responsible Party): | 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: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| 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: | July 2013 |
| Estimated Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: A |
Drug: Pregabalin
150, 300, 450 mg/day administered orally TID, until seizure control/improvement or intolerable side effects
|
| Active Comparator: B |
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 54 Study Locations| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT00537940 History of Changes |
| Other Study ID Numbers: | A0081143 |
| Study First Received: | September 28, 2007 |
| Last Updated: | January 17, 2012 |
| Health Authority: | Spain: Agencia Española del Medicamento y Productos Sanitarios |
|
Epilepsy Epilepsies, Partial Seizures Epilepsy, Complex Partial Brain Diseases Central Nervous System Diseases Nervous System Diseases Neurologic Manifestations Signs and Symptoms Gabapentin Pregabalin Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs |
Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Anticonvulsants Antiparkinson Agents Anti-Dyskinesia Agents Calcium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Cardiovascular Agents Anti-Anxiety Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs Excitatory Amino Acid Antagonists |