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Beeline Clinical Trial Expands to Europe

The Phase 3 Beeline clinical trial is now expanding into Europe.

The Beeline study is a global clinical trial evaluating an investigational treatment, Radiprodil, for individuals with GRIN-related neurodevelopmental disorders (GRIN-NDD). This expansion represents a significant milestone in ongoing efforts to develop targeted therapies for this rare condition. 

About the Beeline Study

The Beeline trial is a Phase 3 (late-stage) clinical study designed to assess the safety and effectiveness of radiprodil.

Radiprodil is an investigational medicine that aims to act on the underlying biological mechanism of certain GRIN disorders, rather than only addressing symptoms. Specifically, it targets overactivity in a part of the brain known as the NMDA receptor, which plays a key role in brain signaling. 

The study will evaluate whether this treatment can improve outcomes such as:

  • Seizure control
  • Behaviour and development
  • Daily functioning and overall clinical condition 

Study Design

The trial includes participants from 1 month through 18 years of age who have a confirmed diagnosis of GRIN-NDD with specific genetic variants.

Participants are assigned to receive either:

  • The investigational treatment (Radiprodil), or
  • A placebo (inactive treatment) during the initial study period

After this phase, eligible participants may continue into an open-label extension, in which all participants have the opportunity to receive the active treatment. [clinicaltrials.gov]

Importantly, the study includes both:

  • Individuals with quantifiable motor seizures
  • Individuals with significant developmental and behavioral symptoms, even if seizures are limited or not present 

European Study Locations

As part of the global expansion, clinical trial sites are being initiated across several European countries, including:

  • Belgium
  • France
  • Germany
  • Italy
  • Poland
  • The Netherlands
  • Slovenia
  • Spain 

These sites complement existing study locations in the United States and the United Kingdom, forming a broad international network to support participation. 

For more information about the trial or about the sites, please check the European Clinical Trial website:  https://euclinicaltrials.eu/search-for-clinical-trials/?lang=en&EUCT=2023-509672-42-00 . Click on “locations and contact points” to learn more about the hospitals that are participating. 

Check out different trials websites with contact details here: https://clinicaltrials.gov/study/NCT07224581?term=beeline&viewType=Card&rank=1

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