Pregabalin Versus Levetiracetam In Partial Seizures
Tracking Information
Start Date ICMJE | October 2007 |
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Estimated Primary Completion Date | May 2012 (final data collection date for primary outcome measure) |
Current Primary Outcome Measures ICMJE (submitted: December 19, 2007) | The primary outcome is efficacy - the responder rate, defined as the proportion of subjects who had at least a 50% reduction in 28 day seizure rate during the maintenance phase, as measured from baseline (data collected during 6 weeks). [ Time Frame: 22 weeks ] [ Designated as safety issue: No ] |
Original Primary Outcome Measures ICMJE (submitted: September 27, 2007) | The primary outcome is efficacy - the responder rate, defined as the proportion of subjects who had at least a 50% reduction in 28 day seizure rate during the maintenance phase, as measured from baseline (data collected during 6 weeks). |
Change History | Complete list of historical versions of study NCT00537238 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures ICMJE (submitted: December 19, 2007) |
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Original Secondary Outcome Measures ICMJE (submitted: September 27, 2007) | Safety and tolerability - Change in seizure count frequency from baseline to endpoint, calculated as the percent change in 28 day seizure frequency during the maintenance phase of treatment compared with baseline. |
Descriptive Information
Brief Title ICMJE | Pregabalin Versus Levetiracetam In Partial Seizures |
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Official Title ICMJE | A Randomized, Double-Blind, Parallel-Group Multi-Center Comparative Flexible-Dose Study Of Pregabalin Versus Levetiracetam As Adjunctive Therapy To Reduce Seizure Frequency In Subjects With Partial Seizures |
Brief Summary | This study will compare pregabalin and leveracitam in patients with partial seizures. It will also evaluate the safety and tolerability of pregabalin and levetiracetam in these patients. |
Detailed Description | |
Study Phase | Phase III |
Study Type ICMJE | Interventional |
Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety/Efficacy Study |
Condition ICMJE |
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Intervention ICMJE |
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Study Arms / Comparison Groups |
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Recruitment Information
Estimated Enrollment ICMJE | 570 | ||||
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Estimated Completion Date | May 2012 | ||||
Estimated Primary Completion Date | May 2012 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE |
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Location Countries ICMJE | Belgium, Bulgaria, Colombia, Czech Republic, France, Germany, Greece, India, Italy, Korea, Republic of, Lithuania, Mexico, Peru, Philippines, Russian Federation, Spain, Taiwan, Turkey, Venezuela |
Administrative Information
NCT ID ICMJE | NCT00537238 | ||||
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Responsible Party | Director, Clinical Trials Disclosure Group, Pfizer, Inc. | ||||
Study ID Numbers ICMJE | A0081157 | ||||
Study Sponsor ICMJE | Pfizer | ||||
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Investigators ICMJE |
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Information Provided By | Pfizer |
Source: http://clinicaltrials.gov/