NE3107 Activity and Safety in Patients With Parkinson's Disease Using Levodopa

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

Dementia
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

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

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