Phase 3
N=175
A Safety, Efficacy, and Tolerability Trial of Pregabalin as Add-On Treatment in Pediatric Subjects <4 Years of Age With Partial Onset Seizures.
Partial Onset Seizures
Bottom Line
View on ClinicalTrials.gov: NCT02072824 ↗Enrolled (actual)
175
Serious AEs
2.9%
Results posted
Oct 2018
Primary outcome: Primary: Log Transformed 24-Hour Seizure Rate for All Partial Onset Seizures During the Double-Blind Treatment Phase — 1.69; 1.15; 1.58 seizures per 24 hours — p=0.4606
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Pregabalin Dose Level 1 (Drug); Pregabalin Dose Level 2 (Drug); Placebo (Drug)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Primary completion
- Mar 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Log Transformed 24-Hour Seizure Rate for All Partial Onset Seizures During the Double-Blind Treatment Phase |
1.69; 1.15; 1.58 | 0.4606 |
| SECONDARY Responder Rate: Percentage of Participants With at Least 50 Percent (%) or Greater Reduction From Baseline in 24-Hour Seizure Rate for All Partial Onset Seizures During the Double-Blind Treatment Phase |
30.51; 53.57; 41.51 | 0.2418 |
Summary
This study is designed to evaluate the effectiveness of 2 doses of pregabalin to reduce seizure frequency as an add on therapy in pediatric subjects 1 month to <4 years of age with refractory partial onset seizures. It is hypothesized that both doses of pregabalin will demonstrate superior efficacy when compared to placebo by reducing the partial onset seizure frequency and that pregabalin will be safe and well tolerated.
Eligibility Criteria
Inclusion Criteria
- Subject must have 3 partial onset seizures in the month prior to screening.
- Subject must have 2 partial onset seizures during the 48 hour baseline phase.
- Signed Informed Consent.
- On 1-3 stable anti-epileptic drugs at screening.
Exclusion Criteria
- Primary generalized seizures including clonic, tonic, clonic-tonic, absence, febrile seizures, and infantile spasms.
- Lennox-Gasteau, BECTS, and Dravet's syndrome.
- Status epliepticus within 1 year of screening.
- Any change in AED regimen with 7 days of screening.
- Progressive structural central nervous system (CNS) lesion or a progressive encephalopathy.
- Progressive errors of metabolism.
Data sourced from ClinicalTrials.gov (NCT02072824). 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.