Trials / Active Not Recruiting
Active Not RecruitingNCT05818553
A Clinical Trial of PRAX-562 in Subjects With Developmental and Epileptic Encephalopathies (DEE)
A Phase 2,Double-Blind,Randomized Clinical Trial to Explore the Safety,Tolerability,Efficacy, and Pharmacokinetics of PRAX-562 in Pediatric Participants With Developmental and Epileptic Encephalopathies Followed by Open-Label Extension(OLE)
- Status
- Active Not Recruiting
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 77 (estimated)
- Sponsor
- Praxis Precision Medicines · Industry
- Sex
- All
- Age
- 1 Year – 18 Years
- Healthy volunteers
- Not accepted
Summary
A Clinical Trial of PRAX-562 in Subjects With Developmental and Epileptic Encephalopathies (DEE)
Detailed description
A Phase 2, double-blind, randomized clinical trial to evaluate the safety and tolerability of PRAX 562 in pediatric participants with SCN2A- and SCN8A- DEEs.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | PRAX-562 | Once daily oral or G-tube treatment. |
Timeline
- Start date
- 2023-08-02
- Primary completion
- 2025-11-12
- Completion
- 2027-03-01
- First posted
- 2023-04-19
- Last updated
- 2026-01-29
Locations
8 sites across 4 countries: United States, Israel, Spain, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05818553. Inclusion in this directory is not an endorsement.