partial onset seizures
Conditions
Interventions
Subjects who complete the baseline phase and meet the eligibility criteria will
be randomized in a double blind manner at Visit 3 to a fixed dose of either of
the following. Study drug will be admin
Sponsors
Pfizer
Eligibility
Age
2 Years to 11 Years
Inclusion criteria
Inclusion criteria: 1. Evidence of a personally signed and dated informed consent document indicating that the parent(s)/guardian(s) have been informed of all pertinent aspects of the study. When there are 2 parents, or 2 guardians, consent should be obtained from both of the child*s parents/guardians if present at the meeting where the informed consent document is signed. 2. Subjects and Parent(s)/guardian(s)/caregiver(s) who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. 3. Male and female subjects, 1 month (44 weeks gestational age) through
Exclusion criteria
Exclusion criteria: 1. Primary generalized seizures (including in the setting of co existing partial onset seizures) which may 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. 2. Lennox Gastaut syndrome, Benign Epilepsy with Centrotemporal Spikes (BECTS) and Dravet syndrome. 3. A current diagnosis of febrile seizures or seizures related to an ongoing acute medical illness. 4. Exacerbation of partial onset seizures due to fever occurring within 60 days of screening. 5. Status epilepticus within 1 year prior to screening. 6. Seizures related to acute medical illness. 7. Any change in AED regimen (type of medication or dose) within 7 days of the Screening Visit or during the Baseline Phase. 8. Progressive structural central nervous sytem (CNS) lesion or a progressive encephalopathy. 9. Progressive errors of metabolism. 10. Known or suspected chronic hematologic, hepatic or renal disease (AST and ALT) above 3 times the upper limit of normal (ULN); or bilirubin, BUN, or creatinine above 2 times the ULN within the previous 6 months prior to screening). Subjects who experienced neonatal hyperbilirubinemia may be included after consulting with the study clinician. 11. Estimated creatinine clearance (ClCR) 30.0 kg.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Efficacy Endpoint * The primary endpoint will be the log transformed double blind 24 hr seizure rate for all partial onset seizures collected at Visit 6 (48 hour Video EEG assessment phase) during the double blind phase as determined by the central reader. This 24 hour seizure rate will be calculated as follows for the double blind phase: * When the log transformation is used, the quantity is added to the double blind 24 hr EEG seizure rate for all subjects to account for any possible "0" seizure incidence. This will result in the following primary efficacy measure: loge (double blind 24 hr EEG seizure rate + ). Results will be reported as *percent change in seizures* relative to placebo. For example, a difference between one of the pregabalin doses and placebo of 0.400 on the log transformed scale for the double blind 24 hr seizure rate, corresponding to a 33% reduction in the double blind 24 hour EEG seizure rate of the pregabalin group from the placebo group (ie, 100%*[exp 0.400 1]= 33%]). * A minimum of 24 hours of evaluable Video EEG will be required to utilize the EEG. In cases where there is less than 24 hours of evaluable Video EEG, the seizure rate will be set to missing. * The baseline 24 hour EEG seizure rate will be calculated in the same way. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Efficacy Endpoint * Responder Rate, defined as subjects who have a *50% reduction from baseline in partial seizure rate during the double blind 48 hour EEG period. Subjects meeting this criterion will be considered responders. Safety Endpoints * The evaluation of safety will include adverse event (AE) data (occurrence, nature, intensity, and relationship to study drug), assessment of clinical laboratory data and the results of physical examinations, vital signs, neurological examinations and electrocardiograms (ECGs). | — |
Countries
Netherlands
Outcome results
None listed