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NE3107 for Overactive Bladder

Phase 1 & 2
Waitlist Available
Research Sponsored by BioVie Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up aims will be measured during the 8 hour period of observation on day 1, 2, 3, 14, and 28

Summary

This trial is testing NE3107, a new drug, in Parkinson's patients who have morning 'off' periods despite taking their usual medication. The goal is to see if NE3107 can improve symptom control when used with their current treatment.

Eligible Conditions
  • Overactive Bladder
  • Parkinson's Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~aims will be measured during the 8 hour period of observation on day 1, 2, 3, 14, and 28
This trial's timeline: 3 weeks for screening, Varies for treatment, and aims will be measured during the 8 hour period of observation on day 1, 2, 3, 14, and 28 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change from baseline (day 1) in Motor disease society- Unified Parkinson's disease rating scale Part III total score for the patient in the "off-state" (without L-dopa for previous eight hours)
Change from baseline in Non-Motor Symptom Assessment Scale for Parkinson Disease (NMSS)
Change from baseline in average Motor disease society- Unified Parkinson's disease rating scale Part III total score measured over the course of 8 hours after taking L-dopa and/or NE3107
+10 more

Side effects data

From 2022 Phase 2 trial • 23 Patients • NCT05227820
4%
Diarrhea
4%
Dizziness
4%
COVID-19 Infection
4%
Tachycardia
4%
Elevated Lipase
4%
Urinary Tract Infection
4%
Knee Injury
4%
Dry Mouth
100%
80%
60%
40%
20%
0%
Study treatment Arm
Experimental Arm: NE3107

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: NE3107Experimental Treatment1 Intervention
orally administered NE3107 20 mg twice daily (BID)
Group II: placeboPlacebo Group1 Intervention
orally administered placebo, twice daily
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
NE3107
2021
Completed Phase 3
~510

Find a Location

Who is running the clinical trial?

BioVie Inc.Lead Sponsor
5 Previous Clinical Trials
488 Total Patients Enrolled
~12 spots leftby Nov 2025