A Phase 3, Randomized, Multi-Center, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Relutrigine in Participants with Developmental and Epileptic Encephalopathies Followed by an Open-Label Extension
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
160
Once daily orally or gastronomy/jejunostomy
Once daily orally or gastronomy/jejunostomy
Once daily orally or gastronomy/jejunostomy
Praxis Research Site
La Jolla, California, United States
RECRUITINGPraxis Research Site
Gulf Breeze, Florida, United States
RECRUITINGPraxis Research Site
Chevy Chase, Maryland, United States
To assess the effect of relutrigine on seizure frequency in participants with DEEs compared to placebo
Change from baseline in monthly motor seizure frequency
Time frame: 16 weeks
Achieve >50% reduction in monthly seizure frequency from baseline
Proportion of patients achieving \>50% reduction in monthly seizure frequency from baseline
Time frame: 16 weeks
Change in seizure-free days
Change in seizure-free days from baseline
Time frame: 16 weeks
Clinical Global Impression-Severity questionnaire
CGI-S at baseline after 16 weeks
Time frame: 16 weeks
Clinical Global Impression-Improvement questionnaire
CGI-I subdomains scores after 16 weeks
Time frame: 16 weeks
Caregiver Global Impression-Severity questionnaire
CgGI-S at baseline after 16 weeks
Time frame: 16 weeks
Caregiver Global Impression-Improvement questionnaire
CgGI-I subdomains scores after 16 weeks
Time frame: 16 weeks
To evaluate the safety and tolerability of relutrigine in participants with DEEs
Incidence and severity of TEAEs
Time frame: 16 weeks
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Praxis Research Site
Roseville, Minnesota, United States
RECRUITINGPraxis Research Site
São Paulo, Brazil
RECRUITINGColumbia-Suicide Severity Rating Scale questionnaire
Incidence of suicidal ideation or behavior as measured by the C-SSRS
Time frame: 16 weeks
Evaluate the safety and tolerability of relutrigine in participants with DEEs
Incidence of clinically significant ECG abnormalities
Time frame: 16 weeks
To evaluate the safety labs and tolerability of relutrigine in participants with DEEs
The principal investigator (PI) or sub investigator will review the laboratory report and document this review. Any clinically significant adverse changes occurring during the clinical trial will be documented as adverse events.
Time frame: 16 weeks
To evaluate the change in respiratory rate and tolerability of relutrigine in participants with DEEs
Change in respiratory rate in breaths per minute
Time frame: 16 weeks
To evaluate the change in blood pressure and tolerability of relutrigine in participants with DEEs
Change in blood pressure in mm/Hg
Time frame: 16 weeks
To evaluate the change in pulse and tolerability of relutrigine in participants with DEEs
Change in heart rate in beats per minute
Time frame: 16 weeks
To evaluate the change in body temperature and tolerability of relutrigine in participants with DEEs
Change in tympanic temperature in Celsius
Time frame: 16 weeks