Phase 3
N=295
A Study of the Efficacy and Safety of Pregabalin as Add-On Therapy for Partial Onset Seizures in Children Ages 4-16 Years
Epilepsy, Partial Seizures
Bottom Line
View on ClinicalTrials.gov: NCT01389596 ↗Enrolled (actual)
295
Serious AEs
7.5%
Results posted
Mar 2017
Primary outcome: Primary: Log-Transformed 28-Day Seizure Rate For All Partial Onset Seizures During Baseline Phase — 3.27; 3.19; 3.18 Seizures per 28 days
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Pregabalin add-on therapy (Drug)
- Age
- Pediatric · 4+ yrs
- Sex
- All
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Primary completion
- Aug 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Log-Transformed 28-Day Seizure Rate For All Partial Onset Seizures During Baseline Phase |
3.27; 3.19; 3.18 | — |
| PRIMARY Log-Transformed 28-Day Seizure Rate For All Partial Onset Seizures During 12-Week Treatment Phase |
2.86; 2.74; 2.96 | 0.2577 |
| SECONDARY Percentage of Participants With at Least 50 Percent (%) or Greater Reduction From Baseline in 28-day Seizure Rate During the 12 Week Treatment Phase |
29.1; 40.6; 22.6 | 0.8024 |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01389596). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.