NPT 2042 for Epilepsy

Overseen By Daryl Hochman

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: NeuroPro Therapeutics, Inc.

Must not be taking: Prescription drugs, Enzyme inducers

Disqualifiers: Cardiovascular, Malignancy, Long QT, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 7 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and behavior of a new medication, NPT 2042, in healthy adults. Participants will take either a single dose or repeated doses to observe the body's reaction over time. The study seeks healthy men and women who can easily swallow capsules and have no major health issues, such as heart or liver problems. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Will I have to stop taking my current medications?

Yes, you will need to stop taking any prescription drugs 14 days before the study and any nonprescription drugs, supplements, or vitamins 7 days before the study, except for acetaminophen at a dose of 2000 mg/day or less.

Is there any evidence suggesting that NPT 2042 is likely to be safe for humans?

Research shows that NPT 2042 is a new treatment currently being tested for safety in humans. Specific safety information for NPT 2042 is not yet available, but similar epilepsy treatments, such as lacosamide and levetiracetam, have been studied and found to be well-tolerated without serious side effects.

This trial is in an early stage, meaning the treatment is just beginning to be tested in humans. The main goal is to determine if NPT 2042 is safe and how the body processes it. As testing has just begun, safety information is still being collected. However, the lack of serious side effects in similar drugs is reassuring regarding its potential safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about NPT 2042 because it offers a novel approach to treatment, potentially differing from existing options by its unique oral soft-gelatin capsule form, which may improve absorption and ease of use. This treatment also shows promise due to its varied dosing regimens, including both single-dose and every 12-hour dosing options, which could offer flexibility and better adherence for patients. Unlike typical options that might take longer to show effects, NPT 2042 has the potential to deliver results more quickly, especially in higher doses.

What evidence suggests that NPT 2042 could be effective?

Research has shown that NPT 2042 could be a promising new treatment for epilepsy. Early data suggest it might outperform current anti-seizure medications. In this trial, participants will receive varying dosages of NPT 2042 to test its effectiveness in reducing seizure frequency and duration. This suggests NPT 2042 might better control seizures in people with genetic generalized epilepsy (GGE). Although human data remain limited, these early results are encouraging. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

Inclusion Criteria

All females must have a negative serum pregnancy test at Screening and a negative serum pregnancy test upon admission to the clinical research center.

You can swallow pills.

Females must be of nonchild-bearing potential defined as permanently sterile (i.e., due to hysterectomy) or postmenopausal (defined as more than one year since last menstrual period).

Exclusion Criteria

History or evidence of adverse symptoms associated with phlebotomy or blood donation (e.g., prolonged bleeding after injury or shaving, frequent epistaxis or gingival bleeding, bruises easily).

Reported use of or inability to refrain from or anticipated use of during the study any prescription drug within 14 days prior to dosing; any nonprescription drug, nutritional supplement, or vitamin within 7 days prior to dosing; NOTE: acetaminophen is allowed at a dose of ≤2000 mg/day any known enzyme-inducer or enzyme-inhibitor including St. John's Wort within 28 days prior to dosing, or reported chronic exposure to enzyme inducers such as paint solvents or pesticides within 30 days of dosing.

Supine blood pressure (BP) less than 80/50 mmHg or greater than 140/90 mmHg.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive single and repeated ascending doses of NPT 2042

7 days

Daily visits for dosing and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• NPT 2042

How Is the Trial Designed?

Group I: Part B; Cohort 3 Experimental Treatment 1 Intervention

Every 12-hour dosing of 80mg (7 days)

Group II: Part B; Cohort 2 Experimental Treatment 1 Intervention

Every 12-hour dosing of 40mg (7 days)

Group III: Part B; Cohort 1 Experimental Treatment 1 Intervention

Every 12-hour dosing of 20mg (7 days)

Group IV: Part A; Cohort 3 Experimental Treatment 1 Intervention

QD dosing of 160mg (1 day)

Group V: Part A; Cohort 2 Experimental Treatment 1 Intervention

QD dosing of 50mg (1 day)

Group VI: Part A; Cohort 1 Experimental Treatment 1 Intervention

QD dosing of 10mg (1 day)

Who Is Running the Clinical Trial?

NeuroPro Therapeutics, Inc.

Lead Sponsor

Trials

3

Recruited

70+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07222878

Study to Evaluate the Relative Bioavailability of a New ... These data include demographics, such as age, sex/gender, race and ethnicity, and study-specific measures (for example, systolic blood pressure, ...

2. ctv.veeva.com ctv.veeva.com/study/a-study-evaluating-npt-2042-versus-placebo-in-subjects-aged-16-75-years-with-genetic-generalized-epi

A Study Evaluating NPT 2042 Versus Placebo in Subjects ... This study will compare the effect of NPT 2042 and placebo in subjects with GGE on the frequency and duration of electroencephalographic ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05503511

Safety and Pharmacokinetic Study of NPT 2042 Soft- ... NPT 2042 CL 101 is a first in human (FIH) study to evaluate the safety and pharmacokinetics (PK) of single and repeated ascending doses of NPT 2042 in healthy ...

4. neuropro.io neuropro.io/providers/

Providers - Learn About Our Upcoming Epilepsy Drug ... NeuroPro's lead molecule, NPT 2042, is one of these drug candidates. The nonclinical data suggest that NPT 2042 may be more efficacious than existing ASMs, and ...

5. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06769659/a-study-evaluating-npt-2042-versus-placebo-in-subjects-aged-16-75-years-with-genetic-generalized-epilepsy-gge-and-absence-seizures

A Study Evaluating NPT 2042 Versus Placebo in Subjects ... This study will compare the effect of NPT 2042 and placebo in subjects with GGE on the frequency and duration of electroencephalographic ...

6. withpower.com withpower.com/trial/phase-1-alzheimer-disease-9-2022-2b254

Safety and Pharmacokinetic Study of NPT 2042 Soft-gelatin ... This trial is testing a new drug, NPT 2042, on healthy adults to ensure it is safe. The goal is to eventually use it to help people with epilepsy who don't ...

7. ctv.veeva.com ctv.veeva.com/study/safety-and-pharmacokinetic-study-of-npt-2042-soft-gelatin-capsules-administered-orally-to-healthy-ad

Safety and Pharmacokinetic Study of NPT 2042 Soft-gelatin ... The long-term goal of this program is to develop NPT 2042 an adjunct antiseizure treatment for patients with medically intractable epilepsy.

8. withpower.com withpower.com/trial/phase-1-epilepsy-reflex-7-2024-d78e7

NPT 2042 for Epilepsy · Info for Participants There is no specific safety data available for NPT 2042, but similar treatments like lacosamide and levetiracetam have been studied. Lacosamide has been shown ...