RECRUITING

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

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2025-03-11

Study Completion:2025-08-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06769659

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:16 Years to 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	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

Inclusion Criteria

Exclusion 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

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

Contacts and Locations

Study Contact

JoAnn Giannone

CONTACT

9196371566

joann@npt.io

Charles Moser

CONTACT

chuckmoser.nlc@gmail.com

Study Locations (Sites)

Clinical Trials, Inc. (CTI)

Little Rock, Arkansas, 77205

United States

Collaborators and Investigators

Sponsor: NeuroPro Therapeutics, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-11

Study Completion Date2025-08-30

Study Record Updates

Study Start Date2025-03-11

Study Completion Date2025-08-30

Terms related to this study

Additional Relevant MeSH Terms

Epilepsy, Generalized
Epilepsy, Absence