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

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Parkinson Disease

In brief

A 28-day phase 2a, double-blind, placebo-controlled (1:1), multi-center study of 20 mg NE3107, twice daily of safety, potential drug-drug interactions, and MDS-UPDRS defined activity in patients with Parkinson's disease . Study will enroll 40 patients that are currently taking immediate release levodopa/ carbidopa (IRLC) and have a practically defined early morning off-state for IRLC. Day one- baseline UPDRS and IRLC PK sampling; day 2- start NE3107 dosing, assess UPDRS during onset and NE3107 PK sampling, rescue meds as needed after 4 hours; day 3 and 14- NE3107 + IRLC UPDRS assessment and PK sampling; day 28- NE3107 + IRLC UPDRS assessments. Optional overnight stays in clinic prior to Day 1-3, 14, and 28.

Key facts

Study ID

NCT05083260

Run by

BioVie Inc.

People needed

46

Starts

2022-01-04

Expected to finish

2023-01-04

Last updated by the study team

2023-02-08

Who can join

Age: 30 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Men or women at least 30 and no more 80 years of age
• Diagnosis of PD consistent with UK Brain Bank Criteria or MDS Research Criteria for the Diagnosis of PD, with bradykinesia and a clear motor response to levodopa
• Stable doses of all PD medications for at least 4 weeks prior to Screening
• Carbidopa/levodopa dose of at least 300 mg daily, distributed over a minimum of 3 dosing intervals during waking hours
• Participants must have history of motor fluctuations with reliable early-morning OFF episodes and a history of a good response to levodopa, in the judgement of the investigator
• If of reproductive potential, willing and able to use a highly effective form of birth control during the study and for 30 days following last dose of study drug. Examples of highly effective forms of birth control are:
• Surgical sterility (via vasectomy, hysterectomy, or bilateral tubal ligation) or postmenopausal status in females
• Sexual partner who is sterile or of the same sex
• Double-barrier method (any combination of physical and chemical methods)
• Intrauterine device in females not containing hormones.
• Able and willing to comply with study drug administration, scheduled visits, treatment plan, laboratory tests, and other study-related procedures to complete the study
• Investigational Review Board/Ethics Committee-approved consent form signed and date by the participant
• Assessed as an appropriate and suitable candidate by the Enrollment Authorization Committee (EAC)

You may not qualify if…

• Diagnosis of secondary or atypical parkinsonism
• Severe or disabling fluctuations or dyskinesias that would, in the opinion of the investigator, interfere with completion of the study
• Clinically significant cognitive impairment
• Clinically significant hallucinations or delusions
• Clinically significant orthostatic hypotension
• Currently active major depression as determined by BDI-II score of >19
• Previous surgical procedure for PD (Duopa, DBS, etc.)
• History of small bowel or gastric surgery
• History of clinically significant GI abnormality (inflammatory bowel disease, significant motility disorder or emesis of any cause, etc.)
• Use of long-acting levodopa formulations (Sinemet CR, ER, Rytary, etc.)
• Routine use of proton pump inhibitors or H2 blockers
• Routine use of medications that may influence gastric motility (opiates, TCA antidepressants, anticholinergics, etc.)
• Other clinically significant medical, surgical, psychiatric, or laboratory abnormality that, in the judgment of the investigator, is likely to interfere with study compliance or assessment of safety or efficacy
• 14) Evidence of significant hepatic impairment according to Child-Pugh criteria, history of cirrhosis, and/or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels greater than 2.5 times the upper limit of normal (ULN), evidence of ascites, hepatic encephalopathy, bilirubin greater than 2 mg/dL, albumin less than 2.0 g/dL, and INR of 1.5 and greater
• Significant renal impairment as determined by creatinine clearance (CrCL) less than or equal to 50 mL/min
• Participant has an ECG or clinical evidence of potentially unstable heart disease, including the following:
• QTcF > 470 msec females; > 450 msec males
• Complete right or left bundle branch block
• Ischemia or myocardial infarct within 1 year prior to the Screening Visit
• Clinically significant atrial or ventricular dysrhythmia; the heart must be in predominantly normal sinus rhythm
• Second- or third-degree AV block
• Heart failure of NYHA classification III or greater
• Serious cardiomyopathy or cardiac structural abnormality
• Symptomatic coronary artery or ischemic cardiac disease
• Any other cardiac condition that the Investigator feels may predispose the participant to ischemia or arrhythmia.

Where it is running

• Rocky Mountain Movement Disorders Center — Englewood, Colorado, United States
• Parkinson's Disease & Movement Disorders Center Of Boca Raton — Boca Raton, Florida, United States
• Velocity — Hallandale, Florida, United States
• Charter Research — Lady Lake, Florida, United States
• Premier Clinical Research Institute — Miami, Florida, United States
• First Excellent Research Group — Miami, Florida, United States
• First Excellent Research — Miami, Florida, United States
• EZY Medical Research — Miami, Florida, United States
• Charter Research — Winter Park, Florida, United States
• Quest Research Institute — Farmington Hills, Michigan, United States
• New York Neurology Associates — New York, New York, United States
• Duke University — Durham, North Carolina, United States
• M3 Wake Research — Raleigh, North Carolina, United States
• University of Toledo — Toledo, Ohio, United States
• Texas Institute for Neurological Disorders — Sherman, Texas, United States
• Inland Northwest Research — Spokane, Washington, United States

Full record on ClinicalTrials.gov

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