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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 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. The trial reports 5 study locations across 5 states.
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
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07010471
The ClinicalTrials.gov registry entry for NCT07010471 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 160 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Praxis Precision Medicines, which has 13 total studies on file at ClinicalTrials.gov.
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 reports 5 study locations spanning 5 distinct geographic areas - top geographies include 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.
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