A Safety, Efficacy, and Tolerability Trial of Pregabalin as Add-On Treatment in Pediatric Subjects <4 Years of Age With Partial Onset Seizures.
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|ClinicalTrials.gov Identifier: NCT02072824|
Recruitment Status : Completed
First Posted : February 27, 2014
Last Update Posted : July 17, 2018
|Condition or disease||Intervention/treatment||Phase|
|Partial Onset Seizures||Drug: Pregabalin Dose Level 1 Drug: Pregabalin Dose Level 2 Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||175 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||A Double-blind, Placebo-controlled, Parallel-group, Multicenter Study Of The Efficacy And Safety Of Pregabalin As Adjunctive Therapy In Children 1 Month Through <4 Years Of Age With Partial Onset Seizures|
|Actual Study Start Date :||September 2014|
|Actual Primary Completion Date :||March 2018|
|Actual Study Completion Date :||March 2018|
|Experimental: Study Drug Level 1||
Drug: Pregabalin Dose Level 1
Pregabalin liquid dosed daily three times a day in equally divided doses escalated to 7.0 mg/kg/day beginning at Randomization through Taper Phase then tapered to 3.5 mg/kg/day during 1 week Taper Phase
|Experimental: Study Drug Level 2||
Drug: Pregabalin Dose Level 2
Pregabalin liquid dosed daily three times a day in equally divided doses escalated to 14.0 mg/kg/day beginning at Randomization through Taper Phase then tapered to 3.5 mg/kg/day during 1 week Taper Phase
|Placebo Comparator: Placebo||
Placebo Liquid dosed three times daily beginning at Randomization through Taper Phase
- Percent reduction of 24 hour seizure rate for all partial onset seizures relative to placebo during the double-blind assessment phase. [ Time Frame: Video-EEG recordings for a target minimum of 48 hours ]Percent reduction of partial onset seizures during the double-blind assessment phase, collected by video-EEG recording.
- Responder rate, defined as the proportion of subjects who had at least a 50% reduction in 24 hour partial onset seizure rate. [ Time Frame: calculated from 48 hour basline through the 2 week double-blind treatment phase ]The proportion of subjects who have at least a 50% reduction in 24 hour partial onset seizure rate during the double-blind assessment phase, as measured from baseline (data collected during the 48 hour baseline video-EEG phase).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02072824
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|Study Director:||Pfizer CT.gov Call Center||Pfizer|