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NPT 2042 for Epilepsy

Phase 1
Recruiting
Research Sponsored by NeuroPro Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subjects receiving zero to three concomitant antiseizure medications (ASMs).
Individuals aged 18-75 years at the time of consent.
Must not have
Subject has a clinically significant medical condition that would interfere with the subject's ability to participate in the study (e.g. active cancer, cardiac disease, renal insufficiency, or active infectious processes).
Subject has a history of non-epileptic seizures (e.g., metabolic, structural, or pseudoseizures).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 4 months
Awards & highlights

Summary

This trial will test the effects of a new drug on 5 participants with a known stable condition using EEG. The participants will receive two different doses of the drug and a placebo in a randomized order.

Who is the study for?
This trial is for a small group of about 5 people who have epilepsy that reacts to flashing lights, known as photosensitive epilepsy. They must have a stable photoparoxysmal response (PPR) on an EEG test.
What is being tested?
The study tests NPT 2042's ability to suppress the PPR in patients with photosensitive epilepsy. It's a controlled experiment where participants receive two different doses of NPT 2042 and a placebo at different times without knowing which one they're getting.
What are the potential side effects?
Since specific side effects are not provided, generally, new medications like NPT 2042 could potentially cause headaches, dizziness, nausea or other reactions depending on individual tolerance and the drug’s profile.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am taking up to three medications for seizures.
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I am between 18 and 75 years old.
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I have been diagnosed with psychogenic pseudoseizures, with or without epilepsy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have any major health issues that would prevent me from joining the study.
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I have had seizures not caused by epilepsy.
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I am not pregnant or breastfeeding.
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I do not have any active brain infections or diseases that worsen over time.
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I have a significant liver condition or a family history of severe liver problems.
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I am not taking any medication, food, or supplements that are not allowed.
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I've used emergency medication more than once in the last month.
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I have had suicidal thoughts or more than one attempt in my life.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 4 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 4 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Evaluate the change in the adjudicated SPR (standard photosensitivity range)
Secondary study objectives
Change in adjudicated SPR
Explore the duration 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.
+1 more

Trial Design

3Treatment groups
Active Control
Placebo Group
Group I: NPT 2042 240mgActive Control1 Intervention
NPT 2042
Group II: NPT 2042 160mgActive Control1 Intervention
NPT 2042
Group III: PlaceboPlacebo Group1 Intervention
Matching placebo for active comparator.

Find a Location

Who is running the clinical trial?

NeuroPro Therapeutics, Inc.Lead Sponsor
1 Previous Clinical Trials
50 Total Patients Enrolled
1 Trials studying Epilepsy
50 Patients Enrolled for Epilepsy
The Epilepsy Study ConsortiumOTHER
7 Previous Clinical Trials
869 Total Patients Enrolled
7 Trials studying Epilepsy
869 Patients Enrolled for Epilepsy
~6 spots leftby Nov 2024
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