Clinical Trial of Vormatrigine in Adult Patients With Epilepsy

July 31, 2026 updated by: Praxis Precision Medicines

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

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
700

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil
        • Praxis Research Site
    • São Paulo
      • São José do Rio Preto, São Paulo, Brazil
        • Praxis Research Site
  • Germany
      • Bielefeld, Germany, 33617
        • Praxis Research Site
      • Tübingen, Germany, 72076
        • Praxis Research Site
  • Italy
      • Milan, Italy, 20133
        • Praxis Research Site
      • Naples, Italy
        • Praxis Research Site
      • Pavia, Italy, 27100
        • Praxis Research Site
      • Pisa, Italy
        • Praxis Research Site
      • Ponderano, Italy
        • Praxis Research Site
      • Roma, Italy
        • Praxis Research Site
    • Isernia
      • Pozzilli, Isernia, Italy
        • Praxis Research Site
    • Lecco
      • Bosisio Parini, Lecco, Italy
        • Praxis Research Site
  • Poland
      • Bydgoszcz, Poland, 85163
        • Praxis Research Site
      • Katowice, Poland, 40123
        • Praxis Research Site
      • Lublin, Poland
        • Praxis Research Site
      • Warsaw, Poland
        • 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, Florida, United States, 33186
        • Praxis Research Site
      • 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
    • Michigan
      • Plymouth, Michigan, United States, 48170
        • Praxis Research Site
    • Missouri
      • Chesterfield, Missouri, United States, 63005
        • Praxis Research Site
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Praxis Research Site
    • New York
      • Amherst, New York, United States, 14226
        • Praxis Research Site
      • Middletown, New York, United States, 10941
        • Praxis Research Site
      • New York, New York, United States, 10016
        • Praxis Research Site
      • Niagara Falls, New York, United States, 14304
        • Praxis Research Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Praxis Research Site
    • Texas
      • El Paso, Texas, United States, 79912
        • Praxis Research Site
      • Houston, Texas, United States, 77058
        • Praxis Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Up to 2 years
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
Up to 2 years
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
Up to 2 years
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
Up to 2 years
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
Up to 2 years
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.
Up to 2 years
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
Up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Praxis Precision Medicines

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Medical Director, Praxis Precision Medicines

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 27, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 11, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 11, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 17, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 3, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 31, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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