Focal EpilepsyPhase 3POWER2NCT07505004
Randomized Clinical Trial Evaluating the Efficacy and Safety of Vormatrigine in Adults With Focal Seizures
A Phase 3 study testing 40 mg/day vormatrogine for 12 weeks, 30 mg/day vormatrogine for 12 weeks and 20 mg/day vormatrogine for 12 weeks in people with Focal Epilepsy, run by Praxis Precision Medicines at 7 sites in United States.
Trial summary
A multicenter, double-blind, randomized, placebo-controlled clinical trial to evaluate the efficacy and safety of vormatrigine in adults with focal seizures (POWER2) Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Focal Epilepsy
- What is being tested?
- 40 mg/day vormatrogine for 12 weeks, 30 mg/day vormatrogine for 12 weeks and 20 mg/day vormatrogine for 12 weeks
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 7 sitesUnited States
- Study dates
- 29 Jan 2026to May 2027
- 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
- Has a diagnosis of focal onset epilepsy according to the International League Against Epilepsy Classification of Epilepsy (2017).
- Prior to randomization, past evidence by CT or MRI that has ruled out a progressive cause of epilepsy in the judgement of the investigator and/or in consultation with the medical monitor.
- Participant must attest to be taking stable doses of 1 or up to 3 acceptable ASMs for at least 4 weeks prior to screening and during screening prior to Day 1.
- Has at least 4 countable focal onset seizures during the 4 weeks of Observation Period immediately prior to randomization with no more than 21 days seizure free during this period.
- Seizure diary must be completed for ≥80% days in the Observation Period.
Who cannot join
- Participant has had any of the following within the 12-month period preceding trial entry:
- evidence of experiencing pseudo or psychogenic seizures
- cluster seizures where the individual seizures cannot be counted
- an episode of convulsive status epilepticus requiring hospitalization and intubation
- seizures secondary to illicit drug or alcohol use
- Seizures secondary to ongoing infection, neoplasia, demyelinating disease, progressive degenerative disease, metabolic illness deemed progressive, progressive structural lesion or encephalopathy.
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- Previously documented EEG which shows any pattern not consistent with focal etiology of seizures.
- Planned epilepsy surgery during the course of the clinical trial.
- History of any of the following:
- neurosurgery for seizures <1 year prior to enrollment
- radiosurgery <2 years prior to enrollment
- neurostimulator placed <1 year prior to Screening
- neurostimulator placed >1 year prior to Screening but settings have not been stable for at least 2 months prior to Screening
- Active suicidal plan/intent in the past 6 months, or a history of suicide attempt in the last 2 years, or more than 1 lifetime suicide attempt, as confirmed by C-SSRS.
- Has any significant ongoing disease, disorder, laboratory abnormalities, alcohol or drug abuse or dependence, environmental factor, or ongoing or recent history of any psychiatric, medical, or surgical condition.
- Participants with a history of malignancy, myeloproliferative or lymphoproliferative disorders within the past 3 years are excluded.
- History or presence of uncontrolled cardiac diseases including conduction and structural abnormalities.
- Total bilirubin value >1.5×ULN; an ALT or AST value >3×ULN.
- History of or active HIV infection or positive screening result for: HIV 1 or 2 antibodies. Evidence of active hepatitis B or hepatitis C infection, as determined by relevant screening assessments.
- Has received any other experimental or investigational drug, device or other therapy within 30 days or 5 half-lives (whichever is longer) prior to Screening, or any prior use of gene or cell therapy.
- Vigabatrin: Use in the last 5 years without stable visual fields tested twice over the 12 months after the last dose of vigabatrin.
- Felbamate: If used as a concomitant ASM, patients must be on felbamate for at least 2 years, with a stable dose for 2 months prior to Screening. If a patient received felbamate in the past, it must have been discontinued 2 months prior to screening.
- Significant allergic reaction to an ASM(s), including dermatological (e.g. Stevens-Johnson syndrome), hematological, or organ toxicity reactions. Severe reactions do not include simple maculopapular eruption and allergic rhinitis.
- Is pregnant or breastfeeding at the time of Screening or has a positive serum pregnancy test at Screening or is planning to become pregnant during the clinical trial or prior to end of study visit.
- Previous exposure to vormatrigine or known hypersensitivity to any component used in the vormatrigine formulation.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Praxis Research Site
Houston, Texas, 77058
Praxis Research Site
Marlboro, New Jersey, 07746
Praxis Research Site
Miami, Florida, 33133
Praxis Research Site
Miami Lakes, Florida, 33016
Praxis Research Site
Naples, Florida, 34116
Praxis Research Site
Niagara Falls, New York, 14304
Praxis Research Site
Raleigh, North Carolina, 27607
About this study
Official title: A Double-blind, Randomized Clinical Trial Evaluating the Efficacy and Safety of Vormatrigine in Adults With Focal Seizures
A multicenter, double-blind, randomized, placebo-controlled clinical trial to evaluate the efficacy and safety of vormatrigine in adults with focal seizures (POWER2)
Read the detailed description
PRAX-628-322 (POWER 2) is a Phase 3, multicenter, double-blind, randomized, placebo-controlled clinical trial to evaluate the efficacy and safety of vormatrigine in adults with focal seizures.
- Conditions
- Focal Epilepsy
- Being tested
- 40 mg/day vormatrogine for 12 weeks, 30 mg/day vormatrogine for 12 weeks, 20 mg/day vormatrogine for 12 weeks, Placebo
- Keywords
- focal epilepsy
- Medical subject headings
- Epilepsies, Partial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
40 mg/day vormatrogine for 12 weeksDrug
Once daily oral
30 mg/day vormatrogine for 12 weeksDrug
Once daily oral
20 mg/day vormatrogine for 12 weeksDrug
Once daily oral
PlaceboDrug
Once daily oral
| Study group | Role | What they receive |
|---|---|---|
| 40 mg/day vormatrogine for 12 weeks | Experimental | Participants who meet all eligibility criteria will be randomized at Visit 1 (Day 1) to receive 40 mg of vormatrogine Receives: Drug: 40 mg/day vormatrogine for 12 weeks |
| 30 mg/day vormatrogine for 12 weeks | Experimental | Participants who meet all eligibility criteria will be randomized at Visit 1 (Day 1) to receive 30 mg of vormatrogine Receives: Drug: 30 mg/day vormatrogine for 12 weeks |
| 20 mg/day vormatrogine for 12 weeks | Experimental | Participants who meet all eligibility criteria will be randomized at Visit 1 (Day 1) to receive 20 mg of vormatrogine Receives: Drug: 20 mg/day vormatrogine for 12 weeks |
| Placebo per day for 12 weeks | Placebo comparator | Participants who meet all eligibility criteria will be randomized at Visit 1 (Day 1) to receive placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the efficacy of vormatrigine compared to placebo on focal seizure frequency in adults currently taking 1 to 3 ASMs
Median percent change in monthly (28 days) focal seizure frequency from the Screening/Observation Period to the Treatment Period for vormatrogine compared to placebo.
Measured: 12 weeks
Secondary outcomes (10)
To further evaluate the efficacy of vormatrigine compared to placebo on focal seizure frequency in adults currently taking 1 to 3 ASMs
Proportion of participants experiencing a ≥50% reduction in monthly (28 days) focal seizure frequency from the Screening/Observation Period to the Treatment Period (Responder Rate) for vormatrogine compared to placebo
Measured: 12 weeks
To assess trends over time in efficacy of vormatrogine on focal seizure frequency
Percent change in monthly focal seizure frequency from the Screening/Observation Period to the Treatment Period for vormatrogine compared with placebo.
Measured: 12 weeks
To assess the safety and tolerability of vormatrigine in adults with focal seizures
Incidence and severity of TEAEs, including discontinuation of study drug due to TEAEs
Measured: 12 weeks
To assess the safety and tolerability of vormatrigine in adults with focal seizures
Change in tympanic temperature in Celsius
Measured: 12 weeks
To assess the safety and tolerability of vormatrigine in adults with focal seizures
Change in heart rate in beats per minute
Measured: 12 weeks
To assess the safety and tolerability of vormatrigine in adults with focal seizures
Change in blood pressure in mm/Hg
Measured: 12 weeks
To assess the safety and tolerability of vormatrigine in adults with focal seizures
Change in respiratory rate in breaths per minute
Measured: 12 weeks
To assess the safety and tolerability of vormatrigine in adults with focal 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: 12 weeks
To assess the safety and tolerability of vormatrigine in adults with focal seizures
Incidence of clinically significant ECG abnormalities
Measured: 12 weeks
To assess the safety and tolerability of vormatrigine in adults with focal seizures
Changes in suicidality, as assessed by Columbia-Suicide Severity Rating Scale
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2026
- Study start29 Jan 2026
- Primary completionJan 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Focal EpilepsyStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Praxis Precision Medicines
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Praxis Precision Medicines, Study director, Praxis Precision Medicines
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07505004
- Sponsor's protocol ID
- PRAX-628-322
- Acronym
- POWER2
- Status last verified
- Jul 2026
- First submitted
- 26 Mar 2026
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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
- A Double-blind, Randomized Clinical Trial Evaluating the Efficacy and Safety of Vormatrigine in Adults With Focal Seizures
- ClinicalTrials.gov ID
- NCT07505004
- Acronym / sponsor ID
- POWER2 / PRAX-628-322
- Conditions
- Focal Epilepsy
- Keywords
- focal epilepsy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Praxis Precision MedicinesIndustry (pharma, biotech, devices)
- Study start
- 29 Jan 2026 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 1 Apr 2026 (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.
A multicenter, double-blind, randomized, placebo-controlled clinical trial to evaluate the efficacy and safety of vormatrigine in adults with focal seizures (POWER2)
Detailed description
PRAX-628-322 (POWER 2) is a Phase 3, multicenter, double-blind, randomized, placebo-controlled clinical trial to evaluate the efficacy and safety of vormatrigine in adults with focal seizures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 40 mg/day vormatrogine for 12 weeks | Experimental | Drug: 40 mg/day vormatrogine for 12 weeksParticipants who meet all eligibility criteria will be randomized at Visit 1 (Day 1) to receive 40 mg of vormatrogine |
| 30 mg/day vormatrogine for 12 weeks | Experimental | Drug: 30 mg/day vormatrogine for 12 weeksParticipants who meet all eligibility criteria will be randomized at Visit 1 (Day 1) to receive 30 mg of vormatrogine |
| 20 mg/day vormatrogine for 12 weeks | Experimental | Drug: 20 mg/day vormatrogine for 12 weeksParticipants who meet all eligibility criteria will be randomized at Visit 1 (Day 1) to receive 20 mg of vormatrogine |
| Placebo per day for 12 weeks | Placebo comparator | Drug: PlaceboParticipants who meet all eligibility criteria will be randomized at Visit 1 (Day 1) to receive placebo |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Has a diagnosis of focal onset epilepsy according to the International League Against Epilepsy Classification of Epilepsy (2017).
- Prior to randomization, past evidence by CT or MRI that has ruled out a progressive cause of epilepsy in the judgement of the investigator and/or in consultation with the medical monitor.
- Participant must attest to be taking stable doses of 1 or up to 3 acceptable ASMs for at least 4 weeks prior to screening and during screening prior to Day 1.
- Has at least 4 countable focal onset seizures during the 4 weeks of Observation Period immediately prior to randomization with no more than 21 days seizure free during this period.
- Seizure diary must be completed for ≥80% days in the Observation Period.
Key exclusion criteria (25 listed)
- Participant has had any of the following within the 12-month period preceding trial entry:
- Seizures secondary to ongoing infection, neoplasia, demyelinating disease, progressive degenerative disease, metabolic illness deemed progressive, progressive structural lesion or encephalopathy.
- Previously documented EEG which shows any pattern not consistent with focal etiology of seizures.
- Planned epilepsy surgery during the course of the clinical trial.
- History of any of the following:
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 |
|---|---|---|
| 40 mg/day vormatrogine for 12 weeksOnce daily oral | Drug | 40 mg/day vormatrogine for 12 weeks |
| 30 mg/day vormatrogine for 12 weeksOnce daily oral | Drug | 30 mg/day vormatrogine for 12 weeks |
| 20 mg/day vormatrogine for 12 weeksOnce daily oral | Drug | 20 mg/day vormatrogine for 12 weeks |
| PlaceboOnce daily oral | Drug | Placebo per day for 12 weeks |
Primary outcome
To evaluate the efficacy of vormatrigine compared to placebo on focal seizure frequency in adults currently taking 1 to 3 ASMs
Time frame: 12 weeks
Median percent change in monthly (28 days) focal seizure frequency from the Screening/Observation Period to the Treatment Period for vormatrogine compared to placebo.
10 secondary outcomes
To further evaluate the efficacy of vormatrigine compared to placebo on focal seizure frequency in adults currently taking 1 to 3 ASMs
Time frame: 12 weeks
To assess trends over time in efficacy of vormatrogine on focal seizure frequency
Time frame: 12 weeks
To assess the safety and tolerability of vormatrigine in adults with focal seizures
Time frame: 12 weeks
To assess the safety and tolerability of vormatrigine in adults with focal seizures
Time frame: 12 weeks
To assess the safety and tolerability of vormatrigine in adults with focal seizures
Time frame: 12 weeks
To assess the safety and tolerability of vormatrigine in adults with focal seizures
Time frame: 12 weeks
To assess the safety and tolerability of vormatrigine in adults with focal seizures
Time frame: 12 weeks
To assess the safety and tolerability of vormatrigine in adults with focal seizures
Time frame: 12 weeks
To assess the safety and tolerability of vormatrigine in adults with focal seizures
Time frame: 12 weeks
To assess the safety and tolerability of vormatrigine in adults with focal seizures
Time frame: 12 weeks
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. This study is not recruiting at the moment.
Praxis Precision Medicines study director
Praxis Precision Medicines
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 40 mg/day vormatrogine for 12 weeks, 30 mg/day vormatrogine for 12 weeks and 20 mg/day vormatrogine for 12 weeks in people with Focal Epilepsy, run by Praxis Precision Medicines at 7 sites in United States.
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 5 inclusion and 25 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: under way, not looking for participants, 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 7 sites in United States. 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. Some participants in this study may receive a placebo. 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 evaluate the efficacy of vormatrigine compared to placebo on focal seizure frequency in adults currently taking 1 to 3 ASMs (time frame: 12 weeks). 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.