COMPLETED

A Double Blind, Randomized, Cross-over Study Examining the Suppression of the Photoparoxysmal EEG Response With NPT 2042

Conditions

Quick Navigation

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

A double-blind, placebo-controlled, crossover trial to investigate the PPR of approximately 5 subjects with a known stable PPR on EEG, using 2 doses of NPT 2042 compared to placebo.

Official Title

A Double Blind, Randomized, Cross-over Study Examining the Suppression of the Photoparoxysmal EEG Response With NPT 2042

Quick Facts

Study Start:2024-08-21

Study Completion:2025-06-26

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT06525649

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:18 Years to 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Subject or legal authorized representative/guardian must be able to provide written informed consent signed prior to any study-specific procedures being conducted. 2. Individuals aged 18-75 years at the time of consent. 3. Subject has a diagnosis and history of a PPR with or without a diagnosis of epilepsy. 4. Subjects receiving zero to three concomitant antiseizure medications (ASMs). * Benzodiazepines: the chronic use of a benzodiazepine for any indication will be allowed and will be counted as an ASM. * Vagus nerve stimulator (VNS)/responsive neurostimulation (RNS): VNS/RNS will not be counted toward the number of concomitant ASMs. Subjects with surgically implanted VNS/RNS will be allowed to enter the study if all the following conditions are met: * The device has been in place for 1 year or more prior to the screening visit. * The settings have remained constant for 3 months or more prior to the screening visit and remain constant throughout the study. * The battery is expected to last for the duration of the study. 5. At least 3 of the EEGs performed during the screening visit must have an intermittent photic stimulation (IPS)-induced SPR of ≥3 points on a frequency assessment scale in the same eye condition, with documented confirmation by the Epilepsy Study Consortium, Inc. (ESCI). 6. Subject is in otherwise good health (with the exception of epilepsy), as determined by the investigator and documented in the medical history. 7. Subject has a body mass index (BMI) between 18 and 40 kg/m2. 8. Subject agrees to refrain from strenuous exercise which is not within the subject's normal daily routine the day before screening, as determined by the investigator. 9. Female subjects of childbearing 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 is able to communicate with the investigator and to understand and comply with all study requirements.	1. Subject has a history of non-epileptic seizures (e.g., metabolic, structural, or pseudoseizures). 2. Females who are pregnant or lactating. 3. Subject has a clinically significant laboratory abnormality that, in the opinion of the investigator, will exclude the subject from the study. 4. Subject has an active central nervous system (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. 5. 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. 6. Subject has clinically significant active liver disease (i.e., liver function tests greater than 3 times the upper limit of normal aspartate aminotransferase (AST), or alanine aminotransferase (ALT), porphyria, or has a family history of severe hepatic dysfunction. 7. Subject has a history of alcoholism, drug abuse, or drug addiction within the past 12 months. 8. Subjects who have participated in any other trials involving an investigational product or device within 30 days or five half-lives (whichever is longer) of Screening. 9. Subject is currently using of any prohibited medication, food or supplement 10. Inability of the investigator to reliably distinguish between spontaneous and provoked spike-wave burst discharges. 11. Subject uses a benzodiazepine as rescue medication within 24 hours of screening. If, in the judgment of the investigator, the subject meets all of the inclusion and none of the other exclusion criteria, rescreening may be done after appropriate wash-out period. If no other rescue medications have been used within the past month, the subject may be eligible for rescreening. 12. Subject has more than one use of rescue medications in the past 30 days. 13. Subject has a history of suicidal thoughts or behaviors in the past 6 months or more than one lifetime suicide attempt. 14. Subject is unable to complete ingestion of 12 placebo SGCs with a minimum of 8 ounces of water at screening. 15. Subject has a clinically significant medical condition that would interfere with the subject's ability to participate in the study (e.g. active cancer, cardiac disease, renal insufficiency, or active infectious processes).

Inclusion Criteria

Exclusion Criteria

1. Subject or legal authorized representative/guardian must be able to provide written informed consent signed prior to any study-specific procedures being conducted.
2. Individuals aged 18-75 years at the time of consent.
3. Subject has a diagnosis and history of a PPR with or without a diagnosis of epilepsy.
4. Subjects receiving zero to three concomitant antiseizure medications (ASMs).
* Benzodiazepines: the chronic use of a benzodiazepine for any indication will be allowed and will be counted as an ASM.
* Vagus nerve stimulator (VNS)/responsive neurostimulation (RNS): VNS/RNS will not be counted toward the number of concomitant ASMs. Subjects with surgically implanted VNS/RNS will be allowed to enter the study if all the following conditions are met:
* The device has been in place for 1 year or more prior to the screening visit.
* The settings have remained constant for 3 months or more prior to the screening visit and remain constant throughout the study.
* The battery is expected to last for the duration of the study.
5. At least 3 of the EEGs performed during the screening visit must have an intermittent photic stimulation (IPS)-induced SPR of ≥3 points on a frequency assessment scale in the same eye condition, with documented confirmation by the Epilepsy Study Consortium, Inc. (ESCI).
6. Subject is in otherwise good health (with the exception of epilepsy), as determined by the investigator and documented in the medical history.
7. Subject has a body mass index (BMI) between 18 and 40 kg/m2.
8. Subject agrees to refrain from strenuous exercise which is not within the subject's normal daily routine the day before screening, as determined by the investigator.
9. Female subjects of childbearing 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 is able to communicate with the investigator and to understand and comply with all study requirements.

1. Subject has a history of non-epileptic seizures (e.g., metabolic, structural, or pseudoseizures).
2. Females who are pregnant or lactating.
3. Subject has a clinically significant laboratory abnormality that, in the opinion of the investigator, will exclude the subject from the study.
4. Subject has an active central nervous system (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.
5. 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.
6. Subject has clinically significant active liver disease (i.e., liver function tests greater than 3 times the upper limit of normal aspartate aminotransferase (AST), or alanine aminotransferase (ALT), porphyria, or has a family history of severe hepatic dysfunction.
7. Subject has a history of alcoholism, drug abuse, or drug addiction within the past 12 months.
8. Subjects who have participated in any other trials involving an investigational product or device within 30 days or five half-lives (whichever is longer) of Screening.
9. Subject is currently using of any prohibited medication, food or supplement
10. Inability of the investigator to reliably distinguish between spontaneous and provoked spike-wave burst discharges.
11. Subject uses a benzodiazepine as rescue medication within 24 hours of screening. If, in the judgment of the investigator, the subject meets all of the inclusion and none of the other exclusion criteria, rescreening may be done after appropriate wash-out period. If no other rescue medications have been used within the past month, the subject may be eligible for rescreening.
12. Subject has more than one use of rescue medications in the past 30 days.
13. Subject has a history of suicidal thoughts or behaviors in the past 6 months or more than one lifetime suicide attempt.
14. Subject is unable to complete ingestion of 12 placebo SGCs with a minimum of 8 ounces of water at screening.
15. Subject has a clinically significant medical condition that would interfere with the subject's ability to participate in the study (e.g. active cancer, cardiac disease, renal insufficiency, or active infectious processes).

Contacts and Locations

Study Locations (Sites)

Clinical Trials, Inc. (CTI)

Little Rock, Arkansas, 77205

United States

Idaho Comprehensive Epilepsy Center

Boise, Idaho, 83702

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 Date2024-08-21

Study Completion Date2025-06-26

Study Record Updates

Study Start Date2024-08-21

Study Completion Date2025-06-26

Terms related to this study

Additional Relevant MeSH Terms

Photosensitive Epilepsy
Epilepsy