A Safety, Efficacy and Tolerability Trial of Pregabalin as Add-On Treatment in Pediatric and Adult Subjects With Primary Generalized Tonic-Clonic (i.e., Grand Mal) Seizures.
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|ClinicalTrials.gov Identifier: NCT01747915|
Recruitment Status : Recruiting
First Posted : December 12, 2012
Last Update Posted : April 10, 2018
|Condition or disease||Intervention/treatment||Phase|
|Generalized Tonic Clonic Seizures||Drug: Pregabalin Dose Level 1 Drug: Pregabalin Dose Level 2 Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||168 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||A Randomized, Double-blind, Placebo-controlled, Parallel Group, Multi-center Trial Of Pregabalin As Adjunctive Therapy In Pediatric And Adult Subjects With Primary Generalized Tonic-clonic Seizures - Protocol A0081105|
|Actual Study Start Date :||April 3, 2013|
|Estimated Primary Completion Date :||June 30, 2019|
|Estimated Study Completion Date :||June 30, 2019|
|Experimental: Study Drug Level 1||
Drug: Pregabalin Dose Level 1
Pregabalin, either liquid or capsule, dosed twice daily, escalated up to a maximum of 300 mg/day beginning at Randomization to Taper Phase, then tapered down to a maximum dose of 150 mg/day during 1 week Taper Phase to End of Study/Early Termination.
Other Name: Lyrica Dose Level 1
|Experimental: Study Drug Level 2||
Drug: Pregabalin Dose Level 2
Pregabalin, either liquid or capsule, dosed twice daily, escalated up to a maximum of 600 mg/day beginning at Randomization to Taper Phase, then tapered down to a maximum of 150 mg/day during 1 week Taper Phase to End of Study/Early Termination.
Other Name: Lyrica Dose Level 2
|Placebo Comparator: Placebo||
Placebo, either liquid or capsule, dosed twice daily beginning at Randomization to End of Study/Early Termination.
- Percent reduction of 28 day seizure rate for all PGTC seizures relative to placebo during the double blind assessment phase. [ Time Frame: Daily PGTC seizure counts collected for up to 21 weeks ]Percent reduction of subject and/or caregiver reported PGTC seizures during the double-blind asessment phase, collected using a daily seizure diary.
- Responder rate, defined as the proportion of subjects who had at least a 50% reduction in 28 day PGTC seizure. [ Time Frame: Calculated from daily data from baseline to end of study for up to 21 weeks ]The proportion of subjects who have at least a 50% reduction in 28 day PGTC seizure rate during the double-blind assessment phase, as measured from baseline (data collected during the 8 week baseline phase) using Seizure Diary data.
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): NCT01747915
|Contact: Pfizer CT.gov Call Center||1-800-718-1021||ClinicalTrials.gov_Inquiries@pfizer.com|
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|Study Director:||Pfizer CT.gov Call Center||Pfizer|