Investigating NPT 2042 for treating photosensitive epilepsy

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

This study is testing if a new treatment called NPT 2042 can help people with photosensitive epilepsy by looking at how their brain reacts to light.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 9 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: NeuroPro Therapeutics, Inc. (Industry-sponsored)
• Locations: 2 sites (Little Rock, Arkansas and 1 other locations)
• Trial ID: NCT06525649 on ClinicalTrials.gov

What this trial studies

This clinical trial is a double-blind, placebo-controlled, crossover study designed to evaluate the effects of two doses of NPT 2042 on the photoparoxysmal electroencephalogram (EEG) response in individuals with a known stable photoparoxysmal response (PPR). Approximately five subjects will participate, receiving either the active treatment or a placebo across three treatment visits, with a minimum 14-day washout period between visits. The PPR will be measured at various time points after dosing to assess the efficacy of NPT 2042 compared to placebo.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18-75 with a diagnosed history of a stable photoparoxysmal response.

Not a fit: Patients with severe epilepsy requiring more than three concomitant antiseizure medications may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients suffering from photosensitive epilepsy.

How similar studies have performed: Other studies have explored treatments for photosensitive epilepsy, but the specific approach using NPT 2042 is novel.

Eligibility criteria

Inclusion 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.

Exclusion Criteria:

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).

Where this trial is running

Little Rock, Arkansas and 1 other locations

• Clinical Trials, Inc. (CTI) — Little Rock, Arkansas, United States (Recruiting)
• Idaho Comprehensive Epilepsy Center — Boise, Idaho, United States (Not_yet_recruiting)

Study contacts

• Study coordinator: JoAnn Giannone

Conditions Photosensitive Epilepsy; Epilepsy