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Tests treatment safety and results for Focal Epilepsy
Official title Double-blind, Randomized Clinical Trial Evaluating the Efficacy and Safety of Vormatrigine in Adults With Focal Seizures
ClinicalTrials.gov ID: NCT07505004
What this study is testing
What is 40 mg/day vormatrogine for 12 weeks?
40 mg/day vormatrogine for 12 weeks is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for focal epilepsy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- A multicenter, double-blind, randomized, placebo-controlled clinical trial to evaluate the efficacy and safety of vormatrigine in adults with focal seizures (POWER2)
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85
You may be able to join if
- 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...
- 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...
- 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 diary must be completed for ≥80% days in the Observation Period.
You likely can't join if
- 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...
See the full eligibility criteria
- 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.
- 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.
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Miami, Florida, United States
- Miami Lakes, Florida, United States
- Naples, Florida, United States
- Marlboro, New Jersey, United States
- Niagara Falls, New York, United States
- Raleigh, North Carolina, United States
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Miami, Florida, United States; Miami Lakes, Florida, United States; Naples, Florida, United States; Marlboro, New Jersey, United States; Niagara Falls, New York, United States; Raleigh, North Carolina, United States and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.