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Clinical Trial of Vormatrigine in Adult Patients With Epilepsy

NCT ID: NCT07287163

Last Updated: 2025-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

PHASE3

Total Enrollment

700 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-27

Study Completion Date

2028-12-31

Brief Summary

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

Detailed Description

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

Conditions

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Primary Generalized Seizure Focal Seizure Epilepsy, Tonic-Clonic

Keywords

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epilepsy tonic-clonic seizure focal

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

vormatrogine

Intervention Type DRUG

Once daily oral

Interventions

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vormatrogine

Once daily oral

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Praxis Precision Medicines

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Praxis Precision Medicines

Locations

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Praxis Research Site

Miami Lakes, Florida, United States

Site Status

Praxis Research Site

Naples, Florida, United States

Site Status

Praxis Research Site

Lafayette, Louisiana, United States

Site Status

Praxis Research Site

Bethesda, Maryland, United States

Site Status

Praxis Research Site

Chesterfield, Missouri, United States

Site Status

Praxis Research Site

Amherst, New York, United States

Site Status

Praxis Research Site

Middletown, New York, United States

Site Status

Praxis Research Site

El Paso, Texas, United States

Site Status

Praxis Research Site

Houston, Texas, United States

Site Status

Praxis Research Site

Bielefeld, , Germany

Site Status

Praxis Research Site

Tübingen, , Germany

Site Status

Praxis Research Site

Milan, , Italy

Site Status

Praxis Research Site

Pavia, , Italy

Site Status

Praxis Research Site

Bydgoszcz, , Poland

Site Status

Praxis Research Site

Katowice, , Poland

Site Status

Praxis Research Site

Barcelona, , Spain

Site Status

Praxis Research Site

Madrid, , Spain

Site Status

Praxis Research Site

Málaga, , Spain

Site Status

Praxis Research Site

Terrassa, , Spain

Site Status

Praxis Research Site

Valencia, , Spain

Site Status

Countries

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United States Germany Italy Poland Spain

Other Identifiers

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PRAX-628-323

Identifier Type: -

Identifier Source: org_study_id