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Clinical Trials in Spain / NCT07287163
Enrolling by invitation Phase 3

Clinical Trial of Vormatrigine in Adult Patients With Epilepsy

NCT07287163 · tracked via the Priya Life Science Spain tracker
Sponsor
Praxis Precision Medicines
Phase
Phase 3
Started
2025-10-27
Last updated
2026-08-03

Condition(s) studied

Epilepsy, Tonic-ClonicFocal SeizurePrimary Generalized Seizure

Investigational drug(s) / intervention(s)

vormatrogine

vormatrogine: Once daily oral

Study summary

Open Label Extension Clinical Trial of Vormatrigine in Adult Patients with Epilepsy

Eligibility

Sex
ALL
Min age
18 Years
Max age
85 Years
Healthy volunteers
No
Inclusion Criteria: * Participant who completed an eligible clinical trial (unless agreed by the sponsor medical monitor), including PRAX-628-212, PRAX-628-321 or other vormatrigine trials, or participant who has received vormatrigine outside of an eligible clinical trial (such as an expanded access program) * Participant who had adequate seizure diary and vormatrigine adherence and had been otherwise adherent to the study procedures in the opinion of the investigator unless deemed unacceptable by sponsor Exclusion Criteria: * Participant who withdrew or discontinued treatment from the treatment period of an eligible clinical trial unless deemed acceptable by the sponsor * Participant who plans to enter another interventional investigational study or is on any prohibited medication * Participant who is pregnant, lactating or planning to become pregnant * Participant who is ineligible for the extension clinical trial in the view of the investigator

Primary outcome measure(s)

  • To assess the safety and tolerability of vormatrigine in adults with focal or primary generalized tonic-clonic seizures — Up to 2 years
    Incidence and severity of TEAEs including discontinuation of study drug due to TEAEs
  • To assess the safety and tolerability of vormatrigine in adults with focal or primary generalized tonic-clonic seizures — Up to 2 years
    Change in tympanic temperature in Celsius
  • To assess the safety and tolerability of vormatrigine in adults with focal or primary generalized tonic-clonic seizures — Up to 2 years
    Change in heart rate in beats per minute
  • To assess the safety and tolerability of vormatrigine in adults with focal or primary generalized tonic-clonic seizures — Up to 2 years
    Change in blood pressure in mm/Hg
  • To assess the safety and tolerability of vormatrigine in adults with focal or primary generalized tonic-clonic seizures — Up to 2 years
    Change in respiratory rate in breaths per minute
  • To assess the safety and tolerability of vormatrigine in adults with focal or primary generalized tonic-clonic seizures — Up to 2 years
    The principal investigator (PI) or sub investigator will review the laboratory report and document this review. Any clinically significant adverse changes occurring during the clinical trial will be documented as adverse events.
  • To assess the safety and tolerability of vormatrigine in adults with focal or primary generalized tonic-clonic seizures — Up to 2 years
    Incidence of clinically significant ECG abnormalities

Trial sites (36)

FacilityCityRegionStatus
Praxis Research Site Miami Florida
Praxis Research Site Miami Lakes Florida
Praxis Research Site Naples Florida
Praxis Research Site Lafayette Louisiana
Praxis Research Site Bethesda Maryland
Praxis Research Site Plymouth Michigan
Praxis Research Site Chesterfield Missouri
Praxis Research Site Hackensack New Jersey
Praxis Research Site Amherst New York
Praxis Research Site Middletown New York
Praxis Research Site New York New York
Praxis Research Site Niagara Falls New York
Praxis Research Site Philadelphia Pennsylvania
Praxis Research Site El Paso Texas
Praxis Research Site Houston Texas
Praxis Research Site Porto Alegre Rio Grande do Sul
Praxis Research Site São José do Rio Preto São Paulo
Praxis Research Site Bielefeld Germany
Praxis Research Site Tübingen Germany
Praxis Research Site Pozzilli Isernia
Praxis Research Site Bosisio Parini Lecco
Praxis Research Site Milan Italy
Praxis Research Site Naples Italy
Praxis Research Site Pavia Italy
Praxis Research Site Pisa Italy
Praxis Research Site Ponderano Italy
Praxis Research Site Roma Italy
Praxis Research Site Bydgoszcz Poland
Praxis Research Site Katowice Poland
Praxis Research Site Lublin Poland
Praxis Research Site Warsaw Poland
Praxis Research Site Barcelona Spain
Praxis Research Site Madrid Spain
Praxis Research Site Málaga Spain
Praxis Research Site Terrassa Spain
Praxis Research Site Valencia Spain

More Praxis Precision Medicines trials in Spain

A Clinical Trial of PRAX-562 in Subjects With Developmental and Epileptic Encephalopathies (DEE) Active, not recruiting
An Open Label Trial to Evaluate the Efficacy and Safety of PRAX-628 in Adults With Focal Onset or Tonic-Clonic Seizures Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07287163 on ClinicalTrials.gov ↗ ← All trials in Spain