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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
Awards & highlights
Study Summary
This trial is testing a new drug for Parkinson's disease to see if it is safe and effective. The trial will last 28 days and enroll 40 patients who are currently taking medication for their Parkinson's.
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 moreTrial 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
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Who is running the clinical trial?
BioVie Inc.Lead Sponsor
5 Previous Clinical Trials
488 Total Patients Enrolled
Frequently Asked Questions
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