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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
5
NPT 2042 is a new drug being developed as an anti-seizure treatment.
Clinical Trials, Inc. (CTI)
Little Rock, Arkansas, United States
Idaho Comprehensive Epilepsy Center
Boise, Idaho, United States
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.
Time frame: Through study completion, an average of 4 months
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.
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.
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.
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.
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
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