A Double Blind, Randomized, Cross-over Study Examining the Suppression of the Photoparoxysmal EEG… (NCT06525649) | Clinical Trial Compass
CompletedPhase 1
A Double Blind, Randomized, Cross-over Study Examining the Suppression of the Photoparoxysmal EEG Response With NPT 2042
United States5 participantsStarted 2024-08-21
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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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).
✓. 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.
Exclusion criteria
✕. 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.
What they're measuring
1
Evaluate the change in the adjudicated SPR (standard photosensitivity range)
Timeframe: Through study completion, an average of 4 months
✕. 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.
✕. 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.