Epilepsy, GeneralizedPhase 2NCT06769659

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

A Phase 2 study testing NPT 2042 in people with Epilepsy, Generalized and Epilepsy, Absence, run by NeuroPro Therapeutics, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 16 to 75 years
Conditions the study is for: Epilepsy, Generalized, Epilepsy, Absence
What is being tested?: NPT 2042
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 14 participants
Where: 1 siteUnited States
Study dates: 11 Mar 2025to 23 Sep 2026
Phase: Phase 2
Are there results?: None posted in the registry

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 16 to 75 years
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

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)
Subject is aged 16-75 years at the time of consent/assent
Subject is diagnosed with genetic generalized epilepsy with absence seizures (consistent with the International League Against Epilepsy (ILAE) Classification of Seizures (2017))
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.
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.
Subject has normal cognition and no clinically significant abnormalities on neurological examination at screening in the opinion of the Investigator

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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
Subject has a body mass index (BMI) between 18 and 40 kg/m2 inclusive, at screening
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
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 cannot join

Subject has metabolic or mitochondrial encephalopathies, seizures associated with structural abnormalities, or infection-related seizures.
Subject has a developmental epileptic encephalopathy (e.g. Lennox-Gastaut syndrome)
Subject has a history of convulsive status epilepticus within the past year.
Subject has a history of surgical intervention for treatment of epilepsy
Subject has a history of nonepileptic seizures (e.g., metabolic, structural, or paroxysmal non epileptic seizures)
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

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Female subject who is pregnant or lactating
Subject has any clinically significant laboratory abnormality which, in the opinion of the investigator, will exclude the subject from the study
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
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:
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)
Study participant has a lifetime history of suicide attempt (including an active attempt, interrupted attempt, or aborted attempt)
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)
Subject has a DSM-V diagnosis of alcohol or drug abuse, or drug addiction within the past 12 months
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
Subject is currently using prohibited medications or products
Subject is unable to complete ingestion of four placebo SGCs with a minimum of eight ounces of water at screening
Subject (and parent/caregiver, if applicable) has daily commitments during the study duration that would interfere with attending all study visits
Positive urine drug test for substance of abuse or illegal recreational substances at screening

Trial locations and contacts

1 site in 1 country.

United States1 site

Clinical Trials, Inc. (CTI)
Little Rock, Arkansas, 77205

Other trials in United States

About this study

Official title: 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

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.

Conditions: Epilepsy, Generalized, Epilepsy, Absence
Being tested: NPT 2042, Placebo
Medical subject headings: Epilepsy, Generalized, Epilepsy, Absence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

NPT 2042Drug
NPT 2042 is a new drug being developed as an anti-seizure treatment
PlaceboOther
Placebo Comparator

Study groups in NCT06769659
Study group	Role	What they receive
NPT 2042 80mg	Active comparator	NPT 2042 80mg BID Receives: Drug: NPT 2042; Other: Placebo
Placebo for NPT 2042 80mg	Placebo comparator	Matching placebo for active comparator Receives: Drug: NPT 2042; Other: Placebo
NPT 2042 160mg	Active comparator	NPT 2042 160mg BID Receives: Drug: NPT 2042; Other: Placebo
Placebo for NPT 2042 160mg	Placebo comparator	Matching placebo for active comparator Receives: Drug: NPT 2042; Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Up to 12 weeks

Secondary outcomes (6)

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.
Measured: Up to 12 weeks
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
Measured: Up to 12 weeks
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
Measured: Up to 12 weeks
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)
Measured: Up to 12 weeks
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
Measured: Up to 12 weeks
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
Measured: Up to 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Mar 202523 Sep 2026

First posted10 Jan 2025
Study start11 Mar 2025
Primary completion17 Aug 2026
Study completion23 Sep 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Epilepsy, GeneralizedStudies 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 14 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06769659
Sponsor's protocol ID: NPT 2042 CL-200
Status last verified: Sep 2026
First submitted: 23 Dec 2024
Last updated: 28 Sep 2026
Results posted: No
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Epilepsy, Generalized trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT06769659
Acronym / sponsor ID: NPT 2042 CL-200
Conditions: Epilepsy, Generalized, Epilepsy, Absence
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 14 participants (actual)
Lead sponsor: NeuroPro Therapeutics, Inc.Industry (pharma, biotech, devices)
Study start: 11 Mar 2025 (actual)
Primary completion: 17 Aug 2026 (actual)
Study completion: 23 Sep 2026 (actual)
First posted: 10 Jan 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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
NPT 2042 80mg	Active comparator	Drug: NPT 2042, Other: PlaceboNPT 2042 80mg BID
Placebo for NPT 2042 80mg	Placebo comparator	Drug: NPT 2042, Other: PlaceboMatching placebo for active comparator
NPT 2042 160mg	Active comparator	Drug: NPT 2042, Other: PlaceboNPT 2042 160mg BID
Placebo for NPT 2042 160mg	Placebo comparator	Drug: NPT 2042, Other: PlaceboMatching placebo for active comparator

Who may qualify

Ages: 16 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (10 listed)

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)
Subject is aged 16-75 years at the time of consent/assent
Subject is diagnosed with genetic generalized epilepsy with absence seizures (consistent with the International League Against Epilepsy (ILAE) Classification of Seizures (2017))
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.
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.

Key exclusion criteria (19 listed)

Subject has metabolic or mitochondrial encephalopathies, seizures associated with structural abnormalities, or infection-related seizures.
Subject has a developmental epileptic encephalopathy (e.g. Lennox-Gastaut syndrome)
Subject has a history of convulsive status epilepticus within the past year.
Subject has a history of surgical intervention for treatment of epilepsy
Subject has a history of nonepileptic seizures (e.g., metabolic, structural, or paroxysmal non epileptic seizures)

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
NPT 2042NPT 2042 is a new drug being developed as an anti-seizure treatment	Drug	NPT 2042 160mg, NPT 2042 80mg, Placebo for NPT 2042 160mg, Placebo for NPT 2042 80mg
PlaceboPlacebo Comparator	Other	NPT 2042 160mg, NPT 2042 80mg, Placebo for NPT 2042 160mg, Placebo for NPT 2042 80mg

Primary outcome

Mean and median across subjects of the within subject difference in percent change from treatment period baseline of the frequency of absence seizures
Time frame: Up to 12 weeks
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.

6 secondary outcomes

Mean and median across subjects of the within subject difference between NPT 2042 and placebo on absence seizures
Time frame: Up to 12 weeks
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
Time frame: Up to 12 weeks
The proportion of NPT 2042- vs. placebo-treated subjects meeting the study specific response criteria
Time frame: Up to 12 weeks
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
The mean change from Baseline in the Digit Symbol Substitution Test
Time frame: Up to 12 weeks
The mean change from Baseline in the Epworth Sleepiness Scale
Time frame: Up to 12 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing NPT 2042 in people with Epilepsy, Generalized and Epilepsy, Absence, run by NeuroPro Therapeutics, Inc. at 1 site 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 10 inclusion and 19 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: finished, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Mean and median across subjects of the within subject difference in percent change from treatment period baseline of the frequency of absence seizures (time frame: Up to 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06769659.

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 28 Sep 2026.