A Clinical Trial for Participants With DEE to Assess Efficacy, Safety, Tolerability, and PK of Relutrigine

Conditions

• Developmental and Epileptic Encephalopathy 1

Eligibility Criteria

Sex

ALL

Age

2 Years - 65 Years

Healthy Volunteers

Not accepted

Interventions

• 1.0mg/kg/day PRAX-562 — DRUG
  Once daily orally or gastronomy/jejunostomy
• 1.5mg/kg/day PRAX-562 — DRUG
  Once daily orally or gastronomy/jejunostomy
• Placebo — DRUG
  Once daily orally or gastronomy/jejunostomy

Study Details

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

Key Dates

Start date

Jul 9, 2025

Status verified

May 2026

Primary completion

Dec 31, 2026

Completion

Nov 30, 2027

Study Design

Enrollment

160 participants (estimated)

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Part A: Double-Blind Treatment Period
  Eligible participants will be randomly assigned in a double-blind manner and a 1:1 ratio to receive 1.0mg-1.5mg/kg relutrigine or placebo once daily orally or gastronomy/jejunostomy for 16 weeks
• Placebo Comparator: Part A: Double-Blind Treatment Period (Placebo)
  Eligible participants will be randomly assigned in a double-blind manner and a 1:1 ratio to receive 1.0mg-1.5mg/kg relutrigine or placebo once daily orally or gastronomy/jejunostomy for 16 weeks
• Experimental: Part B: Open-Label Extension Treatment Period
  Participants from Part A will have the option to rollover to Part B to receive 1.0mg-1.5mg/kg of relutrigine once daily orally or gastronomy/jejunostomy for 32 weeks

Primary Outcome Measure

To assess the effect of relutrigine on seizure frequency in participants with DEEs compared to placebo [ Time Frame: 16 weeks ]

Central Contacts

• Head of Pharmacovigilance
  617-300-8460
  [email protected]

Locations (6)

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