NPT 2042 for Epilepsy

Overseen By JoAnn Giannone

Age: Any Age

Sex: Any

Trial Phase: Phase 2

Sponsor: NeuroPro Therapeutics, Inc.

Must be taking: Antiseizure medications

Disqualifiers: Metabolic encephalopathies, Severe autism, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness of a new treatment, NPT 2042, for individuals with genetic generalized epilepsy (GGE) who experience absence seizures. Researchers aim to determine if this treatment reduces the number and duration of these seizures compared to a placebo. The study includes two treatment periods, during which participants receive either the active drug or a placebo, with a break in between. The trial seeks participants with GGE who frequently experience absence seizures, confirmed by EEG tests. Participants must also have been on a stable dose of their current seizure medication for at least 30 days. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to important early-stage findings.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop your current medications, but it requires that you have been on a stable dose of at least one antiseizure medication for at least 30 days before joining. There is a 14-day washout period (time without taking certain medications) between treatment periods.

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

Research shows that NPT 2042 remains in the early stages of testing to determine its safety for people. Initial studies have examined how the body processes it and have checked for possible side effects. Early data suggest that NPT 2042 might outperform current seizure medications without causing serious side effects. However, as this is an early trial, detailed safety information is not yet available. While the treatment appears promising, researchers are still learning about its safety, and participation in the trial will help gather more information. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for epilepsy?

Unlike the standard treatments for epilepsy, such as antiepileptic drugs like valproate, lamotrigine, and levetiracetam, NPT 2042 stands out with its novel mechanism of action. While most current medications aim to stabilize electrical activity in the brain, NPT 2042 targets a specific pathway that could offer improved seizure control with potentially fewer side effects. Researchers are excited because this could mean a more effective option for patients who don’t respond well to existing therapies. Additionally, the twice-daily (BID) dosing of NPT 2042 might offer more consistent management of symptoms compared to some current options.

What evidence suggests that NPT 2042 might be an effective treatment for epilepsy?

Research has shown that NPT 2042, which participants in this trial may receive, might help reduce seizures in people with epilepsy. It works by affecting GABA, a brain chemical that calms the nerves, potentially leading to fewer seizures. In earlier studies, NPT 2042 lowered the frequency and duration of seizures. Specifically, participants taking NPT 2042 experienced fewer and shorter seizures compared to those on a placebo. While more research is needed, these early results are promising for people with epilepsy. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for people aged 16-75 with Genetic Generalized Epilepsy (GGE) and absence seizures. Participants must meet specific criteria, which are not detailed here.

Inclusion Criteria

I agree to use effective birth control during and for 28 days after the study.

I (or my guardian) have signed the consent form and agree to follow the study rules.

I am between 16 and 75 years old.

Exclusion Criteria

I have a brain disorder related to metabolism or mitochondria, or seizures due to infection or structural brain changes.

I have a severe form of epilepsy like Lennox-Gastaut syndrome.

Subject has severe intellectual disability, severe autism spectrum disorder, or severe developmental disorder such that the subject cannot consent or assent to participate or cannot cooperate with the study procedures

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Period 1

Participants receive either NPT 2042 80 mg BID or matching placebo BID

Up to 12 weeks

Washout

A 14-day washout period between treatment periods

2 weeks

Treatment Period 2

Participants receive the alternate treatment (either NPT 2042 80 mg BID or matching placebo BID)

Up to 12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• NPT 2042
• Placebo

Trial Overview The study tests NPT 2042 against a placebo in reducing the frequency and duration of absence seizures in GGE patients. It's a double-blind, crossover study where participants will take either the drug or placebo twice daily.

How Is the Trial Designed?

Group I: NPT 2042 80mg Active Control 2 Interventions

NPT 2042 80mg BID

Group II: Placebo Placebo Group 2 Interventions

Matching placebo for active comparator

Who Is Running the Clinical Trial?

NeuroPro Therapeutics, Inc.

Lead Sponsor

Trials

3

Recruited

70+

Citations

1. 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 ...

2. neuropro.io neuropro.io/providers/

Providers - Learn About Our Upcoming Epilepsy Drug ... The primary objective of the Phase 2 study is to assess the efficacy of NPT 2042 compared with placebo as an adjunctive treatment for focal-onset epilepsy. How ...

3. 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 ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06525649?term=AREA%5BConditionSearch%5D(%22Epilepsy,%20Reflex%22)&rank=1

Study Details | NCT06525649 | A Double Blind ... This study will compare the effect of 2 doses of NPT 2042 on the photoparoxysmal- electroencephalogram (EEG) response (PPR), compared to placebo.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10501930/

New GABA-Targeting Therapies for the Treatment of Seizures ... The present article summarises available evidence on a number of such treatments in clinical development. These can be broadly divided into three groups.

6. 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.

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

NPT 2042 for Epilepsy · Info for Participants Research shows that NPT 2042 is in the early stages of testing to determine its safety for humans. As this is the first phase of the trial, limited information ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT06769659

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 absence seizures, ...