A Clinical Trial of PRAX-222 in Pediatric Participants With Early Onset SCN2A Developmental and Epileptic Encephalopathy

Part of paid clinical trials in Memphis, Tennessee.

Sponsor
Praxis Precision Medicines
Study ID
NCT05737784
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
2 Years - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • PRAX-222 - Initial Dose — DRUG
    PRAX-222
  • PRAX-222 - Initial Ascending Doses — DRUG
    Ascending doses of PRAX-222
  • PRAX-222 - Optional Ascending Doses — DRUG
    Escalation of PRAX-222 dose(s)
  • PRAX-222 - Fixed Doses — DRUG
    Fixed-dose(s) of PRAX-222 not to exceed the maximum tolerated dose of PRAX-222
  • Placebo — PROCEDURE
    Placebo procedure

Study Details

The goal of this trial is to learn about the effect of PRAX-222 in pediatric participants with early onset SCN2A developmental and epileptic encephalopathy (DEE), aged 2 to 18 years.

Key Dates

Start date
Apr 13, 2023
Status verified
Oct 2024
Primary completion
Aug 31, 2025
Completion
Sep 30, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Preliminary Safety
    Open-label PRAX-222
  • Experimental: Dose Escalation - PRAX-222
    Initial dose escalation consisting of double-blind ascending doses of PRAX-222
  • Placebo Comparator: Dose Escalation - Placebo
    Double-blind placebo procedure
  • Experimental: Optional Dose Escalation - PRAX-222
    Optional dose escalation consisting of double-blind ascending doses of PRAX-222
  • Placebo Comparator: Optional Dose Escalation - Placebo
    Double-blind placebo procedure
  • Experimental: Confirmatory Dosing - PRAX-222
    Double-blind fixed-dose PRAX-222
  • Experimental: Confirmatory Dosing - Placebo
    Double-blind placebo procedure
  • Experimental: Open-label PRAX-222
    Open-label PRAX-222

Primary Outcome Measure

Number of participants with treatment-emergent adverse events (Preliminary Safety, Dose Escalation) [ Time Frame: Screening (-8 weeks) through up to 92 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Le Bonheur Childrens HospitalMemphisTennessee38103-

Find similar trials in Memphis, TN

By condition
Epilepsy
By specialty
NeurologyBrain disorders
By research site
Le Bonheur Childrens Hospital· Memphis, TN

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