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Diuretic
Part A; Cohort 3 for Epilepsy
Phase 1
Waitlist Available
Research Sponsored by NeuroPro Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0 (predose) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24, 30, and 36 hours postdose
Summary
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 respond to current treatments by reducing their seizures.
Eligible Conditions
- Epilepsy
- Alzheimer's Disease
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 0 (predose) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24, 30, and 36 hours postdose
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0 (predose) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24, 30, and 36 hours postdose
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of participants with abnormal ECG
Number of participants with abnormal lab test results
Number of participants with abnormal vital signs
+1 moreSecondary study objectives
Dose proportionality
Pharmacokinetic AUCinf
Pharmacokinetic AUClast
+5 moreTrial Design
6Treatment groups
Experimental Treatment
Group I: Part B; Cohort 3Experimental Treatment1 Intervention
Every 12-hour dosing of 80mg (7 days)
Group II: Part B; Cohort 2Experimental Treatment1 Intervention
Every 12-hour dosing of 40mg (7 days)
Group III: Part B; Cohort 1Experimental Treatment1 Intervention
Every 12-hour dosing of 20mg (7 days)
Group IV: Part A; Cohort 3Experimental Treatment1 Intervention
QD dosing of 160mg (1 day)
Group V: Part A; Cohort 2Experimental Treatment1 Intervention
QD dosing of 50mg (1 day)
Group VI: Part A; Cohort 1Experimental Treatment1 Intervention
QD dosing of 10mg (1 day)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
NPT 2042 (bumetanide analog) or Matching Placebo
2022
Completed Phase 1
~50
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
NeuroPro Therapeutics, Inc.Lead Sponsor
1 Previous Clinical Trials
9 Total Patients Enrolled
1 Trials studying Epilepsy
9 Patients Enrolled for Epilepsy
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