Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT07010471 · ClinicalTrials.gov registry record · Phase 3
A Clinical Trial for Participants With DEE to Assess Efficacy, Safety, Tolerability, and PK of Relutrigine
A Phase 3 study of Developmental and Epileptic Encephalopathy 1, sponsored by Praxis Precision Medicines.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 160
- Enrollment target
- 5
- Study locations
NCT07010471: Recruiting Phase 3 study of Developmental and Epileptic Encephalopathy 1, sponsored by Praxis Precision Medicines.
NCT07010471 is a Phase 3 study of Developmental and Epileptic Encephalopathy 1 that is actively recruiting participants, run by Praxis Precision Medicines. The registered enrollment target is 160 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (79% lower). The trial reports 5 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07010471, a Phase 3 study of Developmental and Epileptic Encephalopathy 1, is actively recruiting participants, sponsored by Praxis Precision Medicines.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 160 participants
- Enrollment target
- 5
- Study locations
Study Summary
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
Primary Outcome
Change from baseline in monthly motor seizure frequency
Conditions Studied
Interventions
- DRUG Placebo
- DRUG 1.0mg/kg/day PRAX-562
- DRUG 1.5mg/kg/day PRAX-562
Study Locations (5)
California
- Praxis Research Site - La Jolla
Florida
- Praxis Research Site - Gulf Breeze
Maryland
- Praxis Research Site - Chevy Chase
Minnesota
- Praxis Research Site - Roseville
Other
- Praxis Research Site - São Paulo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 160 participants |
| Start Date | 2025-07-09 |
| Est. Completion | 2027-07 |
| Phase | Phase 3 |
What NCT07010471 shows while recruiting
NCT07010471 is an interventional study that assigns participants to a tested intervention. The registered 160 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (79% lower).
The record links to 1 condition, with Developmental and Epileptic Encephalopathy 1 appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT07010471 lists 5 locations in 5 states (California, Florida, Maryland).
Frequently Asked Questions
What is clinical trial NCT07010471 about?
NCT07010471 is a clinical study titled "A Clinical Trial for Participants With DEE to Assess Efficacy, Safety, Tolerability, and PK of Relutrigine". 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
What is the current status of trial NCT07010471?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 160 participants. The study started on 2025-07-09. Estimated completion is 2027-07.
What conditions does trial NCT07010471 study?
This clinical trial studies the following conditions: Developmental and Epileptic Encephalopathy 1.
What interventions are being tested in trial NCT07010471?
The interventions under investigation include: Placebo (DRUG), 1.0mg/kg/day PRAX-562 (DRUG), 1.5mg/kg/day PRAX-562 (DRUG).
Who is sponsoring clinical trial NCT07010471?
This trial is sponsored by Praxis Precision Medicines, which has 13 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07010471 being conducted?
This trial has 5 study locations across California, Florida, Maryland, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07010471's enrollment target sits among peer trials
160 1480th of 2000 higher than 500 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00501826 · 160 participants · Phase 2
Combination Chemotherapy and Nelarabine in Treating Patients With T-cell Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma
- NCT00932139 · 160 participants · NA
Effect of Electro-Acupuncture on Blood Pressure
- NCT00992901 · 160 participants · Early Phase 1
Role of Neural and Hormonal Regulation Factors on Insulin Secretion After Gastric Bypass Surgery
- NCT01515527 · 160 participants · Phase 2
Cladribine Plus Low Dose Cytarabine (LDAC) Alternating With Decitabine in Patients With Acute Myeloid Leukemia (AML) or High-Risk Myelodysplastic Syndrome (MDS)
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI