Photosensitive EpilepsyPhase 1NCT06525649
A Double Blind, Randomized, Cross-over Study Examining the Suppression of the Photoparoxysmal EEG Response With NPT 2042
A Phase 1 study testing NPT 2042 in people with Photosensitive Epilepsy and Epilepsy, run by NeuroPro Therapeutics, Inc. at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Photosensitive Epilepsy, Epilepsy
- What is being tested?
- NPT 2042
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5 participants
- Where
- 2 sitesUnited States
- Study dates
- 21 Aug 2024to 26 Jun 2025
- Phase
- Phase 1
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject or legal authorized representative/guardian must be able to provide written informed consent signed prior to any study-specific procedures being conducted.
- Individuals aged 18-75 years at the time of consent.
- Subject has a diagnosis and history of a PPR with or without a diagnosis of epilepsy.
- 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:
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- 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.
- 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).
- Subject is in otherwise good health (with the exception of epilepsy), as determined by the investigator and documented in the medical history.
- Subject has a body mass index (BMI) between 18 and 40 kg/m2.
- 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.
- 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.
- Subject is able to communicate with the investigator and to understand and comply with all study requirements.
Who cannot join
- Subject has a history of non-epileptic seizures (e.g., metabolic, structural, or pseudoseizures).
- Females who are pregnant or lactating.
- Subject has a clinically significant laboratory abnormality that, in the opinion of the investigator, will exclude the subject from the study.
- 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.
- 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.
- 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.
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- Subject has a history of alcoholism, drug abuse, or drug addiction within the past 12 months.
- 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.
- Subject is currently using of any prohibited medication, food or supplement
- Inability of the investigator to reliably distinguish between spontaneous and provoked spike-wave burst discharges.
- 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.
- Subject has more than one use of rescue medications in the past 30 days.
- Subject has a history of suicidal thoughts or behaviors in the past 6 months or more than one lifetime suicide attempt.
- Subject is unable to complete ingestion of 12 placebo SGCs with a minimum of 8 ounces of water at screening.
- 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).
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Idaho Comprehensive Epilepsy Center
Boise, Idaho, 83702
Clinical Trials, Inc. (CTI)
Little Rock, Arkansas, 77205
About this study
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.
Read the detailed description
This study will compare the effect of 2 doses of NPT 2042 on the photoparoxysmal- electroencephalogram (EEG) response (PPR), compared to placebo. Subjects will be screened to ensure they have a stable PPR. Subjects will then return for 3 treatment visits, each lasting 1 day, with minimum 14-day washout period between visits. Subjects will be randomized to a treatment sequence in order to receive NPT 2042 (160 mg or 240 mg) or matching placebo on each treatment day. The PPR will be measured at predose (-0.5 hours) and 0.5, 1, 2, 3, 4, and 6 hours postdose. The PPR of the active treatments will be compared to the placebo response.
- Conditions
- Photosensitive Epilepsy, Epilepsy
- Being tested
- NPT 2042
- Medical subject headings
- Epilepsy, Reflex, Epilepsy
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.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Matching placebo for active comparator. Receives: Drug: NPT 2042 |
| NPT 2042 160mg | Active comparator | NPT 2042 Receives: Drug: NPT 2042 |
| NPT 2042 240mg | Active comparator | NPT 2042 Receives: Drug: NPT 2042 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the change in the adjudicated SPR (standard photosensitivity range)
Evaluate the change in the adjudicated SPR (standard photosensitivity range) in subjects receiving each different dose strengths of NPT 2042 compared to placebo in the most sensitive eye condition. The most sensitive eye condition will be determined at the screening visit.
Measured: Through study completion, an average of 4 months
Secondary outcomes (4)
Change in adjudicated SPR
Evaluate the change in adjudicated SPR in subjects receiving each dose strength of NPT 2042 compared to placebo in all eye conditions.
Measured: Through study completion, an average of 4 months
Explore the time of PPR effect to the NPT 2042 and metabolite plasma concentration-time profiles in the most sensitive eye condition.
Explore the time of PPR effect to the NPT 2042 and metabolite plasma concentration-time profiles in the most sensitive eye condition.
Measured: Through study completion, an average of 4 months
Explore the onset of PPR effect to the NPT 2042 and metabolite plasma concentration-time profiles in all eye conditions.
Explore the onset of PPR effect to the NPT 2042 and metabolite plasma concentration-time profiles in all eye conditions.
Measured: Through study completion, an average of 4 months
Explore the duration of PPR effect to the NPT 2042 and metabolite plasma concentration-time profiles in all eye conditions.
Explore the duration of PPR effect to the NPT 2042 and metabolite plasma concentration-time profiles in all eye conditions.
Measured: Through study completion, an average of 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2024
- Study start21 Aug 2024
- Primary completion26 Jun 2025
- Study completion26 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Photosensitive EpilepsyStudies 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 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- NeuroPro Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The Epilepsy Study Consortium
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06525649
- Sponsor's protocol ID
- NPT 2042 CL-102
- Status last verified
- Jul 2025
- First submitted
- 15 Jul 2024
- Last updated
- 16 Jul 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blind, Randomized, Cross-over Study Examining the Suppression of the Photoparoxysmal EEG Response With NPT 2042
- ClinicalTrials.gov ID
- NCT06525649
- Acronym / sponsor ID
- NPT 2042 CL-102
- Conditions
- Photosensitive Epilepsy, Epilepsy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- NeuroPro Therapeutics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- The Epilepsy Study Consortium
- Study start
- 21 Aug 2024 (actual)
- Primary completion
- 26 Jun 2025 (actual)
- Study completion
- 26 Jun 2025 (actual)
- First posted
- 29 Jul 2024 (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.
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.
Detailed description
This study will compare the effect of 2 doses of NPT 2042 on the photoparoxysmal- electroencephalogram (EEG) response (PPR), compared to placebo. Subjects will be screened to ensure they have a stable PPR. Subjects will then return for 3 treatment visits, each lasting 1 day, with minimum 14-day washout period between visits. Subjects will be randomized to a treatment sequence in order to receive NPT 2042 (160 mg or 240 mg) or matching placebo on each treatment day. The PPR will be measured at predose (-0.5 hours) and 0.5, 1, 2, 3, 4, and 6 hours postdose. The PPR of the active treatments will be compared to the placebo response.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: NPT 2042Matching placebo for active comparator. |
| NPT 2042 160mg | Active comparator | Drug: NPT 2042NPT 2042 |
| NPT 2042 240mg | Active comparator | Drug: NPT 2042NPT 2042 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Subject or legal authorized representative/guardian must be able to provide written informed consent signed prior to any study-specific procedures being conducted.
- Individuals aged 18-75 years at the time of consent.
- Subject has a diagnosis and history of a PPR with or without a diagnosis of epilepsy.
- Subjects receiving zero to three concomitant antiseizure medications (ASMs).
- 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).
Key exclusion criteria (15 listed)
- Subject has a history of non-epileptic seizures (e.g., metabolic, structural, or pseudoseizures).
- Females who are pregnant or lactating.
- Subject has a clinically significant laboratory abnormality that, in the opinion of the investigator, will exclude the subject from the study.
- 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.
- 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.
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 240mg, Placebo |
Primary outcome
Evaluate the change in the adjudicated SPR (standard photosensitivity range)
Time frame: Through study completion, an average of 4 months
Evaluate the change in the adjudicated SPR (standard photosensitivity range) in subjects receiving each different dose strengths of NPT 2042 compared to placebo in the most sensitive eye condition. The most sensitive eye condition will be determined at the screening visit.
4 secondary outcomes
Change in adjudicated SPR
Time frame: Through study completion, an average of 4 months
Explore the time of PPR effect to the NPT 2042 and metabolite plasma concentration-time profiles in the most sensitive eye condition.
Time frame: Through study completion, an average of 4 months
Explore the onset of PPR effect to the NPT 2042 and metabolite plasma concentration-time profiles in all eye conditions.
Time frame: Through study completion, an average of 4 months
Explore the duration of PPR effect to the NPT 2042 and metabolite plasma concentration-time profiles in all eye conditions.
Time frame: Through study completion, an average of 4 months
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 16 Jul 2025.
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NPT 2042 in people with Photosensitive Epilepsy and Epilepsy, run by NeuroPro Therapeutics, Inc. at 2 sites 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 15 inclusion and 15 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 16 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Evaluate the change in the adjudicated SPR (standard photosensitivity range) (time frame: Through study completion, an average of 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Jul 2025; AzTrials last refreshed its copy on 28 Oct 2026.