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| Name | Class |
|---|---|
| The Epilepsy Study Consortium | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Matching placebo for active comparator. |
|
| NPT 2042 160mg | Active Comparator | NPT 2042 |
|
| NPT 2042 240mg | Active Comparator | NPT 2042 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NPT 2042 | Drug | NPT 2042 is a new drug being developed as an anti-seizure treatment. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Through study completion, an average of 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. |
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Inclusion Criteria:
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:
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.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Trials, Inc. (CTI) | Little Rock | Arkansas | 77205 | United States | ||
| Idaho Comprehensive Epilepsy Center |
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| ID | Term |
|---|---|
| D020195 | Epilepsy, Reflex |
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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The subject, investigator, staff, and EEG adjudicator will be blinded to the treatment assignment. All sponsor personnel will be unblinded except the sponsor's study monitor who will remain blinded.
Explore the time of PPR effect to the NPT 2042 and metabolite plasma concentration-time profiles in the most sensitive eye condition. |
| 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. | 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. | Through study completion, an average of 4 months |
| Boise |
| Idaho |
| 83702 |
| United States |