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Enrolling by Invitation

NCT Number: NCT07287163

Clinical Trial of Vormatrigine in Adult Patients With Epilepsy

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

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Key information

Conditions

Epilepsy, Tonic-Clonic Brain Diseases Central Nervous System Diseases Epilepsy Epilepsy, Generalized Focal Seizure Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Primary Generalized Seizure Seizures Signs and Symptoms

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Praxis Research Site, Bielefeld, Germany

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

vormatrogine

Drug

Once daily oral

Primary outcomes

  1. To assess the safety and tolerability of vormatrigine in adults with focal or primary generalized tonic-clonic seizures

    Time frame: Up to 2 years

    Incidence and severity of TEAEs including discontinuation of study drug due to TEAEs

  2. To assess the safety and tolerability of vormatrigine in adults with focal or primary generalized tonic-clonic seizures

    Time frame: Up to 2 years

    Change in tympanic temperature in Celsius

  3. To assess the safety and tolerability of vormatrigine in adults with focal or primary generalized tonic-clonic seizures

    Time frame: Up to 2 years

    Change in heart rate in beats per minute

  4. To assess the safety and tolerability of vormatrigine in adults with focal or primary generalized tonic-clonic seizures

    Time frame: Up to 2 years

    Change in blood pressure in mm/Hg

  5. To assess the safety and tolerability of vormatrigine in adults with focal or primary generalized tonic-clonic seizures

    Time frame: Up to 2 years

    Change in respiratory rate in breaths per minute

  6. To assess the safety and tolerability of vormatrigine in adults with focal or primary generalized tonic-clonic seizures

    Time frame: 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.

  7. To assess the safety and tolerability of vormatrigine in adults with focal or primary generalized tonic-clonic seizures

    Time frame: Up to 2 years

    Incidence of clinically significant ECG abnormalities

Sponsors and collaborators

Lead sponsor

Praxis Precision Medicines

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Dec 17, 2025
Registry last updated
Dec 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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