ClinicalTrials.gg
CompletedNCT06769659Updated Sep 28, 2026

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

A Phase 2 interventional study of NPT 2042 and Placebo in Epilepsy, Generalized and Epilepsy, Absence, sponsored by NeuroPro Therapeutics, Inc.. Completed at 1 site in United States. Open to participants aged 16 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-28.

Primary conditionEpilepsy, AbsenceRegistry: Epilepsy, GeneralizedReclassifiedWhy we changed it
Registry
Epilepsy, Generalized — the first condition term the registry derived for this study.
ClinicalTrials.gg
Epilepsy, Absence
Why
  1. The study's listed conditions name Epilepsy, Absence, a narrower term within Epilepsy, Generalized.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by NeuroPro Therapeutics, Inc. · Phase 2, Interventional, and Treatment

Updated Sep 28, 2026Now CompletedPrimary completion moved+2 moreGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
14
Allocation
Randomized
Ages
16 Years to 75 Years
Sex
All
01

Study summary

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 BID orally or matching placebo BID in each of two treatment periods. Two doses of NPT 2042 will be evaluated.

02

Conditions studied

  • Epilepsy, Generalized
  • Epilepsy, Absence

Browse trials for

03

In context

Epilepsy, Absence Reclassified

24 studies on the registry are indexed under Epilepsy, Absence; 2 are open to participants now.

This study's enrollment of 14 is below the median of 20 across 17 interventional studies indexed under Epilepsy, Absence.

Browse Epilepsy, Absence studies →

Lead sponsor

NeuroPro Therapeutics, Inc. is the lead sponsor of 4 studies on the registry; none are open to participants now.

Compared within Epilepsy, Absence, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Epilepsy, Generalized. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
16 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Subject is capable of and provides consent/assent, and the study participant's parent/legal representative/caregiver provides signed 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 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 (BMI) between 18 and 40 kg/m2 inclusive, at screening
  9. Female subjects of and all men agree to use of highly effective methods of 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

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 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 ( and ALT)
  12. Subject has a diagnosis of alcohol or drug abuse, or drug addiction within the past 12 months
  13. Subject has participated in any other trials involving an 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
Terms in these criteria, in plain language(9)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
14 participants (actual)

Study arms

  • Active comparator
    NPT 2042 80mg

    NPT 2042 80mg BID

    Drug: NPT 2042 · Other: Placebo

  • Placebo comparator
    Placebo for NPT 2042 80mg

    Matching placebo for active comparator

    Drug: NPT 2042 · Other: Placebo

  • Active comparator
    NPT 2042 160mg

    NPT 2042 160mg BID

    Drug: NPT 2042 · Other: Placebo

  • Placebo comparator
    Placebo for NPT 2042 160mg

    Matching placebo for active comparator

    Drug: NPT 2042 · Other: Placebo

Interventions

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

  • OtherPlacebo

    Placebo Comparator

06

What researchers measure

Primary outcomes

  1. Mean and median across subjects of the within subject difference in percent change from treatment period baseline of the frequency of absence seizures

    Mean and median across subjects of the within subject difference in percent change from treatment period baseline of the frequency of absence seizures (defined as 2.5-6 Hz spike-wave bursts lasting greater than 3 seconds) between NPT 2042 and placebo.

    Time frame: Up to 12 weeks

Secondary outcomes

  1. Mean and median across subjects of the within subject difference between NPT 2042 and placebo on absence seizures

    Mean and median across subjects of the within subject difference between NPT 2042 and placebo on absence seizures (defined as 2.5-6 Hz spike-wave bursts lasting greater than 3 seconds) average duration.

    Time frame: Up to 12 weeks

  2. Mean and median across subjects of the within subject categorical difference in percent change between NPT 2042 and placebo of the frequency of absence seizure

    Mean and median across subjects of the within subject categorical difference in percent change between NPT 2042 and placebo of the frequency of absence seizure (defined as 2.5-6 Hz spike wave bursts lasting greater than 3 seconds) using the following categories: * 1 - \< 3 seconds * 3 - 5 seconds * \>5 - 10 seconds * \>10 seconds

    Time frame: Up to 12 weeks

  3. The proportion of NPT 2042- vs. placebo-treated subjects meeting the study specific response criteria

    The proportion of NPT 2042- vs. placebo-treated subjects meeting the following response criteria: * ≥50% decrease in endpoint seizure frequency compared to treatment period baseline * ≥75% decrease in endpoint seizure frequency compared to treatment period baseline * Seizure freedom

    Time frame: Up to 12 weeks

  4. The mean change from Baseline across subjects of the within subject difference between NPT 2042 and placebo on the Quality of Life in Epilepsy Questionnaire (QOLIE-31-P)

    The mean change from Baseline across subjects of the within subject difference between NPT 2042 and placebo on the Quality of Life in Epilepsy Questionnaire (QOLIE-31-P)

    Time frame: Up to 12 weeks

  5. The mean change from Baseline in the Digit Symbol Substitution Test

    The mean change from Baseline in the Digit Symbol Substitution Test following treatment with NPT 2042 compared to placebo

    Time frame: Up to 12 weeks

  6. The mean change from Baseline in the Epworth Sleepiness Scale

    The mean change from Baseline in the Epworth Sleepiness Scale following treatment with NPT 2042 compared to placebo

    Time frame: Up to 12 weeks

07

Study locations

1 site
  • Clinical Trials, Inc. (CTI)
    Little Rock, Arkansas 77205, United States
08

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it moved

Ran from Mar 2025 to primary completion in Aug 2026, 17 months.

Completion moved once since we started tracking on Sep 25, 2026: Oct 2026 → Sep 2026, on Sep 28, 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Dec 23, 2024
First posted
Jan 10, 2025
StartActual
Mar 11, 2025
Primary completionActual
Aug 17, 2026
CompletionActual
Sep 23, 2026was Oct 2026
Last update
Sep 28, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Recruiting→Completed
changed Sep 28, 2026
Primary completion
Aug 30, 2026→Aug 17, 2026 (actual)
Sep 28, 2026
Study completion
Oct 30, 2026→Sep 23, 2026 (actual)
Sep 28, 2026
Enrollment
12 (estimated)→14 (actual)
Sep 28, 2026
Show all 1 update
  1. Sep 28, 2026
    Recruiting→Completed
    Primary completion Aug 30, 2026→Aug 17, 2026 (now actual)
    Study completion Oct 30, 2026→Sep 23, 2026 (now actual)
    Enrollment 12 (estimated)→14 (actual)
    + 3 other changes: verification date, contact details and site details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT06769659
Lead sponsor
NeuroPro Therapeutics, Inc.
Responsible party
Sponsor
First posted
Jan 10, 2025
Start date
Mar 11, 2025
Primary completion
Aug 17, 2026
Completion
Sep 23, 2026
Last update
Sep 28, 2026

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: NPT 2042

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