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Sponsored by: |
Pfizer |
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Information provided by: | Pfizer |
ClinicalTrials.gov Identifier: | NCT00537940 |
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: | September 2009 |
Estimated Primary Completion Date: | September 2009 (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
|
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Pfizer CT.gov Call Center | 1-800-718-1021 |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Responsible Party: | Pfizer, Inc. ( Director, Clinical Trials Disclosure Group ) |
Study ID Numbers: | A0081143 |
Study First Received: | September 28, 2007 |
Last Updated: | December 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00537940 |
Health Authority: | Spain: Agencia Española del Medicamento y Productos Sanitarios |
Epilepsy, Complex Partial Epilepsies, Partial Excitatory Amino Acids Calcium, Dietary Signs and Symptoms Gabapentin |
Epilepsy Seizures Pregabalin Neurologic Manifestations Central Nervous System Diseases Brain Diseases |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Anti-Dyskinesia Agents Physiological Effects of Drugs Psychotropic Drugs Antiparkinson Agents Calcium Channel Blockers Excitatory Amino Acid Agents Membrane Transport Modulators Pathologic Processes Sensory System Agents Therapeutic Uses Analgesics |
Excitatory Amino Acid Antagonists Disease Tranquilizing Agents Nervous System Diseases Central Nervous System Depressants Cardiovascular Agents Antimanic Agents Pharmacologic Actions Anti-Anxiety Agents Peripheral Nervous System Agents Central Nervous System Agents Anticonvulsants |