PRAX-562-102
10 evidence topics · 2 sources
Objective
Healthy-adult pharmacology objectives
Location and study date
No evidence found.
Study design
Eligibility criteria
Healthy-participant age range
Treatment
PRAX-562-102: phase 1 healthy-volunteer study, oxcarbazepine combination, part B treatment
Study outcomes
Rationale for using safety and tolerability as the primary endpoint
Not applicable.
Statistical analysis description
Number of participants (Planned and analyzed)
Description of analysis sets
No evidence found.
Results
Participant disposition
PRAX-562-102: early termination of the combination part
Baseline characteristics
Part A: age, mean (minimum, maximum), years
| Treatment | Age |
|---|---|
| Relutrigine | “38.7 (22, 53)” |
| Placebo | “37.3 (24, 49)” |
Efficacy results
Not applicable.
Health-related quality of life and patient-reported outcomes
Not applicable.
Safety results
PRAX-562-102: serious adverse events and study termination
Study limitations
Summary
This healthy-volunteer study enrolled 48 participants, with 30 in Part A and 18 in Part B. The 28-day treatment design does not establish long-term safety or therapeutic efficacy in pediatric DEE. One participant in the oxcarbazepine combination part experienced three study-drug-related serious adverse events, and Part B stopped early. Findings from that combination and dose should be distinguished from the separate EMBOLD pediatric regimen.