Clinical Trial of Vormatrigine in Adult Patients With Epilepsy

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

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

Study Overview

• Status: Enrolling by invitation
• Conditions: Epilepsy, Tonic-Clonic; Focal Seizure; Primary Generalized Seizure
• Intervention / Treatment: Drug: vormatrogine

Detailed Description

An open label extension clinical trial to assess the safety and tolerability of vormatrigine in adults with focal or primary generalized tonic-clonic seizures.

• Study Type: Interventional
• Enrollment (Estimated): 700
• Phase: Phase 3

Contacts and Locations

Study Locations

• Germany
  • Bielefeld, Germany, 33617
    • Praxis Research Site
  • Tübingen, Germany, 72076
    • Praxis Research Site
• Italy
  • Milan, Italy, 20133
    • Praxis Research Site
  • Pavia, Italy, 27100
    • Praxis Research Site
• Poland
  • Bydgoszcz, Poland, 85163
    • Praxis Research Site
  • Katowice, Poland, 40123
    • Praxis Research Site
• Spain
  • Barcelona, Spain, 08003
    • Praxis Research Site
  • Madrid, Spain, 28040
    • Praxis Research Site
  • Málaga, Spain, 29010
    • Praxis Research Site
  • Terrassa, Spain, 08222
    • Praxis Research Site
  • Valencia, Spain, 46026
    • Praxis Research Site
• United States
  • Florida
    • Miami Lakes, Florida, United States, 33016
      • Praxis Research Site
    • Naples, Florida, United States, 34116
      • Praxis Research Site
  • Louisiana
    • Lafayette, Louisiana, United States, 70508
      • Praxis Research Site
  • Maryland
    • Bethesda, Maryland, United States, 20817
      • Praxis Research Site
  • Missouri
    • Chesterfield, Missouri, United States, 63005
      • Praxis Research Site
  • New York
    • Amherst, New York, United States, 14226
      • Praxis Research Site
    • Middletown, New York, United States, 10941
      • Praxis Research Site
  • Texas
    • El Paso, Texas, United States, 79912
      • Praxis Research Site
    • Houston, Texas, United States, 77058
      • Praxis Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Open-label 30 mg/day vormatrogine for up to 2 years; Participants who meet all eligibility criteria will receive 30 mg of vormatrogine for up to 2 years.	Drug: vormatrogine; Once daily oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To assess the safety and tolerability of vormatrigine in adults with focal or primary generalized tonic-clonic seizures	Incidence and severity of TEAEs including discontinuation of study drug due to TEAEs	Up to 2 years
To assess the safety and tolerability of vormatrigine in adults with focal or primary generalized tonic-clonic seizures	Change in tympanic temperature in Celsius	Up to 2 years
To assess the safety and tolerability of vormatrigine in adults with focal or primary generalized tonic-clonic seizures	Change in heart rate in beats per minute	Up to 2 years
To assess the safety and tolerability of vormatrigine in adults with focal or primary generalized tonic-clonic seizures	Change in blood pressure in mm/Hg	Up to 2 years
To assess the safety and tolerability of vormatrigine in adults with focal or primary generalized tonic-clonic seizures	Change in respiratory rate in breaths per minute	Up to 2 years
To assess the safety and tolerability of vormatrigine in adults with focal or primary generalized tonic-clonic seizures	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.	Up to 2 years
To assess the safety and tolerability of vormatrigine in adults with focal or primary generalized tonic-clonic seizures	Incidence of clinically significant ECG abnormalities	Up to 2 years

Collaborators and Investigators

• Sponsor: Praxis Precision Medicines
• Investigators: Study Director: Medical Director, Praxis Precision Medicines

Study record dates

Study Major Dates

• Study Start (Actual): October 27, 2025
• Primary Completion (Estimated): May 31, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: December 11, 2025
• First Submitted That Met QC Criteria: December 11, 2025
• First Posted (Actual): December 17, 2025

Study Record Updates

• Last Update Posted (Actual): December 17, 2025
• Last Update Submitted That Met QC Criteria: December 11, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: epilepsy; focal; seizure; tonic-clonic
• Additional Relevant MeSH Terms: Neurologic Manifestations; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy, Generalized; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Epilepsy; Seizures; Epilepsy, Tonic-Clonic
• Other Study ID Numbers: PRAX-628-323

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No