A Study of the Efficacy and Safety of Pregabalin as Add-On Therapy for Partial Onset Seizures in Children Ages 4-16 Years

Phase 3

Completed

Brief Summary: Study A0081041 is a double blind, placebo controlled, randomized, parallel group, multicenter study to evaluate the safety and efficacy of two dose levels of pregabalin administered in equally divided daily doses, in either capsule or oral liquid formulation, as adjunctive therapy in pediatric subjects 4 to 16 years of age with partial onset seizures.

Recruitment & Eligibility

Inclusion Criteria

Subjects and/or parent(s)/legally acceptable representative must be considered willing and able to sign consent, and complete daily seizure diaries and monitor seizure frequency.
Male and female epilepsy subjects, 4 to 16 years of age inclusive on the date of the Screening Visit.
Diagnosis of epilepsy with partial onset seizures classified as simple partial, complex partial or partial becoming secondarily generalized, according to the International League Against Epilepsy (ILAE) Diagnosis criteria.
Must have a partial onset seizure frequency of at least 3 seizures per 28 day period prior to screening. Must have a partial onset seizure frequency of at least 6 seizures and no continuous 4 week seizure free period during the 8 week baseline phase prior to randomization.
Currently receiving a stable dose of 1 to 3 antiepileptic drugs (stable within 28 days prior to screening).

Exclusion Criteria

Primary generalized seizures (including in the setting of co-existing partial onset seizures) which include, for example: Clonic, tonic and clonic-tonic seizures (note that partial onset seizures that become secondarily generalized are not exclusionary); Absence seizures; Infantile spasms; Myoclonic, myoclonic atonic, myoclonic tonic seizures.
Lennox Gastaut syndrome, Benign Epilepsy with Centrotemporal Spikes (BECTS) and Dravet syndrome.
A current diagnosis of febrile seizures, or seizures related to an ongoing acute medical illness. Any febrile seizures within 1 year of screening.
Status epilepticus within 1 year prior to screening.
Seizures related to drugs, alcohol, or acute medical illness.
Any change in AED regimen (type of medication or dose) within 28 days of the Screening Visit or during the Baseline Phase.
Progressive structural CNS lesion or a progressive encephalopathy.

Arm && Interventions

Primary Outcome Measures

Name	Time	Method
Log-Transformed 28-Day Seizure Rate For All Partial Onset Seizures During Baseline Phase	Baseline phase (up to 8 weeks prior to treatment phase [Day 1])	All partial onset seizures experienced during baseline phase were recorded by the participants or their parents/legal guardian, in a daily seizure diary. 28-day seizure rate for all partial onset seizures = (\[number of seizures in the baseline phase\] divided by \[number of days in baseline phase minus {-} number of missing diary days in baseline phase\])\*28. For log-transformation, the quantity 1 was added to the 28-day seizure rate for all participants to account for any possible "0" seizure incidence. This resulted in final calculation as: log transformed (28-day seizure rate +1).
Log-Transformed 28-Day Seizure Rate For All Partial Onset Seizures During 12-Week Treatment Phase	Day 1 up to Week 12	All partial onset seizures experienced during treatment phase were recorded by the participants or their parents/legal guardian in a daily seizure diary. 28-day seizure rate for all partial onset seizures = (\[number of seizures in the treatment phase\] divided by \[number of days in treatment phase minus {-} number of missing diary days in treatment phase\])\*28. For log-transformation, the quantity 1 was added to the 28-day seizure rate for all participants to account for any possible "0" seizure incidence. This resulted in final calculation as: log transformed (28-day seizure rate +1).

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With at Least 50 Percent (%) or Greater Reduction From Baseline in 28-day Seizure Rate During the 12 Week Treatment Phase	Day 1 up to Week 12	Percentage of participants with 50 percent (%) or greater reduction from baseline in 28-day seizure rate during the 12 week treatment phase were reported. 28-day seizure rate for all partial onset seizures = (\[number of seizures in the treatment phase\] divided by \[number of days in treatment phase minus {-} number of missing diary days in treatment phase\])\*28.

Locations (85): Center for Neurosciences
🇺🇸
Tucson, Arizona, United States
Arkansas Children's Hospital
🇺🇸
Little Rock, Arkansas, United States
Children's Hospital Los Angeles
🇺🇸
Los Angeles, California, United States
Children´s Hospital Los Angeles
🇺🇸
Los Angeles, California, United States
Axcess Medical Research
🇺🇸
Loxahatchee Groves, Florida, United States
Laszlo J. Mate, M.D., P.A.
🇺🇸
North Palm Beach, Florida, United States
Pediatric Neurology, P.A.
🇺🇸
Orlando, Florida, United States
Tallahassee Neurological Clinic
🇺🇸
Tallahassee, Florida, United States
Center for Clinical and Translational Science
🇺🇸
Lexington, Kentucky, United States
Kentucky Neuroscience Institute
🇺🇸
Lexington, Kentucky, United States
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Center for Neurosciences
🇺🇸Tucson, Arizona, United States