Epilepsy, Tonic-ClonicPhase 3NCT07287163
Clinical Trial of Vormatrigine in Adult Patients With Epilepsy
A Phase 3 study testing vormatrogine in people with Epilepsy, Tonic-Clonic and Focal Seizure, run by Praxis Precision Medicines at 36 sites in 6 countries.
Trial summary
Open Label Extension Clinical Trial of Vormatrigine in Adult Patients with Epilepsy Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Epilepsy, Tonic-Clonic, Focal Seizure, Primary Generalized Seizure
- What is being tested?
- vormatrogine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 700 participants
- Where
- 36 sitesin 6 countries
- Study dates
- 27 Oct 2025to 31 Dec 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
36 sites in 6 countries. Contact the study team or a site near you to ask about taking part.
36 sites in 6 countries
United States15 sites
Praxis Research Site
Amherst, New York, 14226
Praxis Research Site
Bethesda, Maryland, 20817
Praxis Research Site
Chesterfield, Missouri, 63005
Praxis Research Site
El Paso, Texas, 79912
Praxis Research Site
Hackensack, New Jersey, 07601
Praxis Research Site
Houston, Texas, 77058
Praxis Research Site
Lafayette, Louisiana, 70508
Praxis Research Site
Miami, Florida, 33186
Praxis Research Site
Miami Lakes, Florida, 33016
Praxis Research Site
Middletown, New York, 10941
Praxis Research Site
Naples, Florida, 34116
Praxis Research Site
New York, New York, 10016
Praxis Research Site
Niagara Falls, New York, 14304
Praxis Research Site
Philadelphia, Pennsylvania, 19107
Praxis Research Site
Plymouth, Michigan, 48170
Italy8 sites
Praxis Research Site
Bosisio Parini, Lecco
Praxis Research Site
Milan, 20133
Praxis Research Site
Naples
Praxis Research Site
Pavia, 27100
Praxis Research Site
Pisa
Praxis Research Site
Ponderano
Praxis Research Site
Pozzilli, Isernia
Praxis Research Site
Roma
Spain5 sites
Praxis Research Site
Barcelona, 08003
Praxis Research Site
Madrid, 28040
Praxis Research Site
Málaga, 29010
Praxis Research Site
Terrassa, 08222
Praxis Research Site
Valencia, 46026
Poland4 sites
Praxis Research Site
Bydgoszcz, 85163
Praxis Research Site
Katowice, 40123
Praxis Research Site
Lublin
Praxis Research Site
Warsaw
Brazil2 sites
Praxis Research Site
Porto Alegre, Rio Grande do Sul
Praxis Research Site
São José do Rio Preto, São Paulo
Germany2 sites
Praxis Research Site
Bielefeld, 33617
Praxis Research Site
Tübingen, 72076
About this study
Official title: Open Label Extension Clinical Trial of Vormatrigine in Adult Patients With Epilepsy
Open Label Extension Clinical Trial of Vormatrigine in Adult Patients with Epilepsy
Read the 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.
- Being tested
- vormatrogine
- Keywords
- epilepsy, tonic-clonic, seizure, focal
- Medical subject headings
- Epilepsy, Tonic-Clonic, Seizures, Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vormatrogineDrug
Once daily oral
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: vormatrogine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2025
- Study start27 Oct 2025
- Primary completion31 May 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epilepsy, Tonic-ClonicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Praxis Precision Medicines
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Praxis Precision Medicines
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07287163
- Sponsor's protocol ID
- PRAX-628-323
- Status last verified
- Jul 2026
- First submitted
- 11 Dec 2025
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label Extension Clinical Trial of Vormatrigine in Adult Patients With Epilepsy
- ClinicalTrials.gov ID
- NCT07287163
- Acronym / sponsor ID
- PRAX-628-323
- Keywords
- epilepsy, tonic-clonic, seizure, focal
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Praxis Precision MedicinesIndustry (pharma, biotech, devices)
- Study start
- 27 Oct 2025 (actual)
- Primary completion
- 31 May 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 17 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Open Label Extension Clinical Trial of Vormatrigine in Adult Patients with Epilepsy
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open-label 30 mg/day vormatrogine for up to 2 years | Experimental | Drug: vormatrogineParticipants who meet all eligibility criteria will receive 30 mg of vormatrogine for up to 2 years. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| vormatrogineOnce daily oral | Drug | Open-label 30 mg/day vormatrogine for up to 2 years |
Primary outcome
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
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
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
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
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
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.
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Medical Director study director
Praxis Precision Medicines
36 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing vormatrogine in people with Epilepsy, Tonic-Clonic and Focal Seizure, run by Praxis Precision Medicines at 36 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites in United States, Italy, Spain, Poland, Brazil and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.