A Phase 2, Single-Blind, Placebo-Controlled, Fixed-Sequence Design Trial to Evaluate the Photoparoxysmal Electroencephalogram Response, Safety, Tolerability, and Pharmacokinetics of PRAX-628 in Participants with Epilepsy and a Photoparoxysmal Electroencephalogram Response to Intermittent Photic Stimulation

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-504803-10-00

Enrollment

Registered

2023-06-09

Start date

2023-06-15

Completion date

2024-03-14

Last updated

2024-03-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

IPS induced photoparoxysmal electroencephalogram response (IPS-induced PPR) in participants with epilepsy and IPS-induced PPR

Brief summary

Reduction or abolishment of the IPS-induced PPR

Detailed description

Plasma concentrations of PRAX-628, Maximum observed concentration (Cmax), Time to maximum observed concentration (tmax), Area under the concentration-time curve from time zero to 24 hours (AUC24), Incidence and severity of adverse events (AEs), Changes in vital sign measurements, Changes in clinical laboratory results, Changes in electrocardiogram (ECG) parameters

Interventions

DRUGPRAX-628

DRUGPlacebo for PRAX-628

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Secondary

Measure	Time frame
Plasma concentrations of PRAX-628, Maximum observed concentration (Cmax), Time to maximum observed concentration (tmax), Area under the concentration-time curve from time zero to 24 hours (AUC24), Incidence and severity of adverse events (AEs), Changes in vital sign measurements, Changes in clinical laboratory results, Changes in electrocardiogram (ECG) parameters	—

Primary

Measure	Time frame
Reduction or abolishment of the IPS-induced PPR	—

Countries

Netherlands

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026