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Unknown

PRAX-222 for Epileptic Encephalopathy

Phase 1 & 2
Recruiting
Research Sponsored by Praxis Precision Medicines
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0 to 4 weeks, 6 to 10 weeks, 12 to 16 weeks, 18 to 22 weeks, 24 to 28 weeks

Summary

This trial will study the effects of PRAX-222 on pediatric patients (2-18) with a rare brain disorder called DEE.

Who is the study for?
This trial is for children aged 2-18 with early onset SCN2A developmental and epileptic encephalopathy, who had seizures start before 3 months old, weigh at least 10 kg, and have a specific genetic variant. Kids can't join if they have other significant genetic changes or are on more than two sodium channel blocking seizure meds.
What is being tested?
The study tests PRAX-222's effects in various doses compared to a placebo. It starts with an initial dose of PRAX-222, followed by increasing amounts if safe, and then settles on fixed doses to see how well it works for these young epilepsy patients.
What are the potential side effects?
While the side effects of PRAX-222 aren't detailed here, similar medications often cause drowsiness, balance issues, gastrointestinal symptoms like nausea or vomiting, potential allergic reactions or skin rashes.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~screening (-8 weeks) through up to 92 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and screening (-8 weeks) through up to 92 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of participants with treatment-emergent adverse events (Preliminary Safety, Dose Escalation)
Secondary study objectives
Behavior as assessed by Aberrant Behaviors Checklist-2nd edition (ABC-2; Confirmatory Phase)
Behavior as assessed by Vineland Adaptive Behavior Scale-3rd edition (Vineland-3; Confirmatory Phase)
Caregiver Global Impression-Improvement (CgGI-I) score (Confirmatory Phase)
+16 more

Trial Design

8Treatment groups
Experimental Treatment
Placebo Group
Group I: Preliminary SafetyExperimental Treatment1 Intervention
Open-label PRAX-222
Group II: Optional Dose Escalation - PRAX-222Experimental Treatment1 Intervention
Optional dose escalation consisting of double-blind ascending doses of PRAX-222
Group III: Open-label PRAX-222Experimental Treatment1 Intervention
Open-label PRAX-222
Group IV: Dose Escalation - PRAX-222Experimental Treatment1 Intervention
Initial dose escalation consisting of double-blind ascending doses of PRAX-222
Group V: Confirmatory Dosing - PlaceboExperimental Treatment1 Intervention
Double-blind placebo procedure
Group VI: Confirmatory Dosing - PRAX-222Experimental Treatment1 Intervention
Double-blind fixed-dose PRAX-222
Group VII: Dose Escalation - PlaceboPlacebo Group1 Intervention
Double-blind placebo procedure
Group VIII: Optional Dose Escalation - PlaceboPlacebo Group1 Intervention
Double-blind placebo procedure
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670

Find a Location

Who is running the clinical trial?

Praxis Precision MedicinesLead Sponsor
9 Previous Clinical Trials
1,119 Total Patients Enrolled
2 Trials studying Epilepsy
25 Patients Enrolled for Epilepsy
Medical DirectorStudy DirectorPraxis Precision Medicines
2,892 Previous Clinical Trials
8,089,262 Total Patients Enrolled
7 Trials studying Epilepsy
1,059 Patients Enrolled for Epilepsy

Media Library

PRAX-222 (Unknown) Clinical Trial Eligibility Overview. Trial Name: NCT05737784 — Phase 1 & 2
Epilepsy Research Study Groups: Preliminary Safety, Dose Escalation - PRAX-222, Dose Escalation - Placebo, Optional Dose Escalation - PRAX-222, Optional Dose Escalation - Placebo, Confirmatory Dosing - PRAX-222, Confirmatory Dosing - Placebo, Open-label PRAX-222
Epilepsy Clinical Trial 2023: PRAX-222 Highlights & Side Effects. Trial Name: NCT05737784 — Phase 1 & 2
PRAX-222 (Unknown) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05737784 — Phase 1 & 2
~18 spots leftby Aug 2025
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