Donate

Praxis Precision Medicines

Praxis Precision Medicines Trial on the
Safety and Efficacy of Relutrigine

The EMERALD Study

The EMERALD study is evaluating a potential new treatment to reduce seizures caused by Developmental and Epileptic Encephalopathies (DEEs).

Joining this study is designed to be as easy as possible for your family, with the flexibility to choose at-home visits, clinic visits, or a mix of both. If you do travel to a clinic, the study covers all costs for your travel, lodging, and meals. Every participant is guaranteed to receive the study medicine at some point, with the option to stay on it for an additional 32 weeks once the first part of the study ends. Most importantly, if your loved one sees a clear benefit from the treatment, there is a program in place to help them keep receiving the medicine even after the trial is completely over.

Relutrigine is an investigational medicine that can be taken orally or administered through a G/J tube. Relutrigine is designed to regulate sodium flow in brain cells by targeting overactive sodium channels that cause seizures; therefore, potentially offering better seizure control with fewer side effects. Relutrigine has been designed to maximize its effects against overactive sodium channels that are believed to cause seizure activity while minimizing the blocking of normal activity needed for healthy brain function.

Clinical Trial - Relutrigine 

  • Drug Candidate: Relutrigine
  • Clinical Sponsor: Praxis
  • Trial Name: EMERALD
  • Gene Eligibility: All GRI Disorders (GRIN, GRIA, GRIK, and GRID)
  • Age Eligibility: 2 years to 65 years
  • Epilepsy Requirement: Yes. Minimum of 4 countable seizures per month.
  • Will patients on placebo get access to the drug candidate? Yes.If a child receives the placebo, they will still gain access to the active Relutrigine drug once the first 16 weeks of the study are finished.
  • Sites Currently Open (Recruiting): US (Maryland). Study is decentralized so patients anywhere in US can participate.
  • Sites Coming: Australia, Brazil, Germany, Italy
  • To Learn More: To learn more about the DEEp Ocean study, you can visit the study-specific website: https://www.resiliencestudies.com/emerald