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Sponsored by: |
Pfizer |
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Information provided by: | Pfizer |
ClinicalTrials.gov Identifier: | NCT00280059 |
The purpose of this study is to assess whether Lyrica is a safe and effective treatment for partial epilepsy in comparison with an established treatment, Lamictal.
Condition | Intervention | Phase |
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Epilepsy, Partial |
Drug: Pregabalin Drug: Lamotrigine |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Comparative, Double-Blind, Parallel-Group, Multicenter, Monotherapy, Study Of Pregabalin (Lyrica) And Lamotrigine (Lamictal) In Patients With Newly Diagnosed Partial Seizures |
Estimated Enrollment: | 626 |
Study Start Date: | August 2006 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: Pregabalin
dose 150-600 mg/day given BID
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2: Active Comparator |
Drug: Lamotrigine
dose 100-500 mg/day given BID
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Ages Eligible for Study: | 16 Years and older |
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: | A0081046 |
Study First Received: | January 18, 2006 |
Last Updated: | April 16, 2009 |
ClinicalTrials.gov Identifier: | NCT00280059 History of Changes |
Health Authority: | United Kingdom: European Medicines Agency |
Epilepsy, partial seizures, pregabalin monotherapy, lamotrigine comparator, double-blind and randomized trial |
Epilepsies, Partial Seizures Central Nervous System Diseases Pregabalin Calcium Channel Blockers Cardiovascular Agents Brain Diseases |
Calcium, Dietary Epilepsy Lamotrigine Analgesics Peripheral Nervous System Agents Anticonvulsants |
Epilepsies, Partial Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Nervous System Diseases Central Nervous System Diseases Pregabalin Calcium Channel Blockers Cardiovascular Agents Brain Diseases Pharmacologic Actions |
Membrane Transport Modulators Sensory System Agents Epilepsy Therapeutic Uses Lamotrigine Peripheral Nervous System Agents Analgesics Central Nervous System Agents Anticonvulsants |