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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ aims will be measured during the 8 hour period of observation on day 1, 2, 3, 14, and 28
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
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 moreSide effects data
From 2022 Phase 2 trial • 23 Patients • NCT052278204%
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
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