Clinical Trial of Vormatrigine in Adult Patients With Epilepsy

NCT07287163 | Enrolling By Invitation Phase 3 FDA Drug

• 1 other identifier: PRAX-628-323
• Study Type: interventional
• Target: 700
• Locations: 5 countries
• Sites: 20

Brief Summary

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

Conditions

Focal Seizure; Primary Generalized Seizure; Epilepsy, Tonic-Clonic

Keywords

epilepsy; tonic-clonic; seizure; focal

Outcome Measures

Primary Outcomes (7)

• 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

Study Arms (1)

Open-label 30 mg/day vormatrogine for up to 2 years

EXPERIMENTAL

Participants who meet all eligibility criteria will receive 30 mg of vormatrogine for up to 2 years.

Drug: vormatrogine

Interventions

vormatrogine DRUG

Once daily oral

Open-label 30 mg/day vormatrogine for up to 2 years

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Praxis Precision Medicines: lead

Study Sites (20)

Praxis Research Site

Miami Lakes, Florida, 33016, United States

Location

Praxis Research Site

Naples, Florida, 34116, United States

Location

Praxis Research Site

Lafayette, Louisiana, 70508, United States

Location

Praxis Research Site

Bethesda, Maryland, 20817, United States

Location

Praxis Research Site

Chesterfield, Missouri, 63005, United States

Location

Praxis Research Site

Amherst, New York, 14226, United States

Location

Praxis Research Site

Middletown, New York, 10941, United States

Location

Praxis Research Site

El Paso, Texas, 79912, United States

Location

Praxis Research Site

Houston, Texas, 77058, United States

Location

Praxis Research Site

Bielefeld, 33617, Germany

Location

Praxis Research Site

Tübingen, 72076, Germany

Location

Praxis Research Site

Milan, 20133, Italy

Location

Praxis Research Site

Pavia, 27100, Italy

Location

Praxis Research Site

Bydgoszcz, 85163, Poland

Location

Praxis Research Site

Katowice, 40123, Poland

Location

Praxis Research Site

Barcelona, 08003, Spain

Location

Praxis Research Site

Madrid, 28040, Spain

Location

Praxis Research Site

Málaga, 29010, Spain

Location

Praxis Research Site

Terrassa, 08222, Spain

Location

Praxis Research Site

Valencia, 46026, Spain

Location

MeSH Terms

Conditions

Epilepsy, Tonic-Clonic; Seizures; Epilepsy

Condition Hierarchy (Ancestors)

Epilepsy, Generalized; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Medical Director

  Praxis Precision Medicines

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2025
• First Posted: December 17, 2025
• Study Start: October 27, 2025
• Primary Completion (Estimated): May 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: December 17, 2025

Record last verified: 2025-12

Locations

US (9); ES (5); DE (2); PL (2); IT (2)