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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

A Study Evaluating NPT 2042 Versus Placebo in Subjects Aged 16-75 Years With Genetic Generalized Epilepsy (GGE) and Absence Seizures

A Single-center, Double-blind, Placebo-controlled Crossover Study Evaluating NPT 2042 Versus Placebo in Subjects Aged 16-75 Years With Genetic Generalized Epilepsy (GGE) and Absence Seizures

A Study Evaluating NPT 2042 Versus Placebo in Subjects Aged 16-75 Years With Genetic Generalized Epilepsy (GGE) and Absence Seizures (NCT06769659) is a Phase 2 interventional studying Epilepsy, Generalized and Epilepsy, Absence, sponsored by NeuroPro Therapeutics, INC.. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

This study will compare the effect of NPT 2042 and placebo in subjects with GGE on the frequency and duration of electroencephalographic absence seizures, separated by a 14-day washout period. The study will be a single-center, double-blind, crossover study with subjects receiving either NPT 2042 80 mg BID orally or matching placebo BID in each of two treatment periods.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Epilepsy, Generalized and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 10 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Subject is capable of and provides consent/assent, and the study participant's parent/legal representative/caregiver provides signed willing to sign a consent form for minor study participants, which includes compliance with the requirements and restrictions listed in the willing to sign a consent form form (ICF) 2. Subject is aged 16-75 years at the time of consent/assent 3. Subject is diagnosed with genetic generalized epilepsy with absence seizures (consistent with the International League Against Epilepsy (ILAE) Classification of Seizures (2017)) 4. Subject has electroencephalogram (EEG) evidence of bilateral synchronous generalized paroxysmal spike-wave (2.5 Hz to 6 Hz) bursts lasting 3 seconds or more at least 4 times on the screening 72-hour ambulatory EEG. 5. Subject has been on a stable dose of at least one antiseizure medication (ASM) for at least 30 days. Vagal nerve stimulation at stable settings (for at least 30 days before screening), without use of the magnet, is also acceptable. 6. Subject has normal cognition and no clinically significant abnormalities on neurological examination at screening in the opinion of the Investigator 7. Subject is in otherwise good health (with the exception of epilepsy), as determined by the investigator, and as documented in the medical history, physical examination, and screening laboratory investigations 8. Subject has a body mass index (BMI) between 18 and 40 kg/m2 inclusive, at screening 9. Female subjects of child-bearing potential and all men agree to use of highly effective methods of contraception during the study and for 28 days after last dose of study drug 10. Subject (and parent/caregiver, if applicable) is able to communicate with the investigator and to understand and comply with all study requirements, including the clinic visit schedule Who Should NOT Join This Trial: ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. Subject is capable of and provides consent/assent, and the study participant's parent/legal representative/caregiver provides signed informed consent for minor study participants, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) 2. Subject is aged 16-75 years at the time of consent/assent 3. Subject is diagnosed with genetic generalized epilepsy with absence seizures (consistent with the International League Against Epilepsy (ILAE) Classification of Seizures (2017)) 4. Subject has electroencephalogram (EEG) evidence of bilateral synchronous generalized paroxysmal spike-wave (2.5 Hz to 6 Hz) bursts lasting 3 seconds or more at least 4 times on the screening 72-hour ambulatory EEG. 5. Subject has been on a stable dose of at least one antiseizure medication (ASM) for at least 30 days. Vagal nerve stimulation at stable settings (for at least 30 days before screening), without use of the magnet, is also acceptable. 6. Subject has normal cognition and no clinically significant abnormalities on neurological examination at screening in the opinion of the Investigator 7. Subject is in otherwise good health (with the exception of epilepsy), as determined by the investigator, and as documented in the medical history, physical examination, and screening laboratory investigations 8. Subject has a body mass index (BMI) between 18 and 40 kg/m2 inclusive, at screening 9. Female subjects of child-bearing potential and all men agree to use of highly effective methods of contraception during the study and for 28 days after last dose of study drug 10. Subject (and parent/caregiver, if applicable) is able to communicate with the investigator and to understand and comply with all study requirements, including the clinic visit schedule Exclusion Criteria: 1. Subject has metabolic or mitochondrial encephalopathies, seizures associated with structural abnormalities, or infection-related seizures. 2. Subject has a developmental epileptic encephalopathy (e.g. Lennox-Gastaut syndrome) 3. Subject has a history of convulsive status epilepticus within the past year. 4. Subject has a history of surgical intervention for treatment of epilepsy 5. Subject has a history of nonepileptic seizures (e.g., metabolic, structural, or paroxysmal non epileptic seizures) 6. Subject has severe intellectual disability, severe autism spectrum disorder, or severe developmental disorder such that the subject cannot consent or assent to participate or cannot cooperate with the study procedures 7. Female subject who is pregnant or lactating 8. Subject has any clinically significant laboratory abnormality which, in the opinion of the investigator, will exclude the subject from the study 9. Subject has an active CNS infection, demyelinating disease, degenerative neurological disease, or any CNS disease deemed to be progressive during the course of the study that may confound the interpretation of the study results 10. Subject has any clinically significant psychiatric illness, psychological or behavioral problems which, in the opinion of the investigator, would interfere with the subject's ability to participate in the study, including but not limited to the following: 1. Subject has active suicidal ideation prior to study entry as indicated by a positive response ("yes") to either Question 4 or Question 5 of the Columbia Suicide Severity Rating Scale (C-SSRS) 2. Study participant has a lifetime history of suicide attempt (including an active attempt, interrupted attempt, or aborted attempt) 11. Subject is suffering from clinically significant active liver disease, porphyria or has a family history of severe hepatic dysfunction indicated by abnormal liver function tests greater than three times the upper limit of normal (AST and ALT) 12. Subject has a DSM-V diagnosis of alcohol or drug abuse, or drug addiction within the past 12 months 13. Subject has participated in any other trials involving an investigational product or device within 30 days of screening or longer, as required by local regulations 14. Subject is currently using prohibited medications or products 15. Subject is unable to complete ingestion of four placebo SGCs with a minimum of eight ounces of water at screening 16. Subject (and parent/caregiver, if applicable) has daily commitments during the study duration that would interfere with attending all study visits 17. Positive urine drug test for substance of abuse or illegal recreational substances at screening

Treatments Being Tested

DRUG

NPT 2042

NPT 2042 is a new drug being developed as an anti-seizure treatment

OTHER

Placebo

Placebo Comparator

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Clinical Trials, Inc. (CTI)
Little Rock, Arkansas, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06769659), the sponsor (NeuroPro Therapeutics, INC.), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06769659 clinical trial studying?

This study will compare the effect of NPT 2042 and placebo in subjects with GGE on the frequency and duration of electroencephalographic absence seizures, separated by a 14-day washout period. The study will be a single-center, double-blind, crossover study with subjects receiving either NPT 2042 80 mg BID orally or matching placebo BID in each of two treatment periods. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06769659?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06769659?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06769659. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06769659. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.