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

Status: Completed
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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:

• 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.

Locations
United States
Arkansas
Clinical Trials, Inc. (CTI)
Little Rock
Idaho
Idaho Comprehensive Epilepsy Center
Boise
Time Frame
Start Date: 2024-08-21
Completion Date: 2025-06-26
Participants
Target number of participants: 5
Treatments
Placebo_comparator: Placebo
Matching placebo for active comparator.
Active_comparator: NPT 2042 160mg
NPT 2042
Active_comparator: NPT 2042 240mg
NPT 2042
Related Therapeutic Areas
Sponsors
Leads: NeuroPro Therapeutics, Inc.
Collaborators: The Epilepsy Study Consortium

This content was sourced from clinicaltrials.gov

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