This is a phase 2 study, randomized, double-blind, placebo-controlled, multicenter study of oral CVN424 at two dose levels (low-dose and high-dose) in Parkinson's disease (PD) patients with motor fluctuations.
Approximately 135 male and female subjects with Parkinson's disease, on a stable dosage of levodopa but with an average of ≥ 2 h total OFF time/day and not less than 1 h per day, will be enrolled. Following baseline safety and efficacy assessments, subjects will be randomized to receive once-daily doses of either low-dose CVN424, high-dose CVN424, or matching placebo. All subjects not randomized to placebo will initiate treatment with a low-dose of CVN424 on Day 1; the low-dose arm will continue to receive their low dose each day, while the high-dose arm will increase their daily dosage to the high-dose CVN424 beginning on Day 8 ±2 days and continuing thereafter. Study drug will be self-administered each morning as an oral suspension. Subjects will continue their other PD medications.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
136
Collaborative Neuroscience Network, LLC
Long Beach, California, United States
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Study Drug
An adverse event is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. TEAEs are defined as any event with onset during or after the first dose of study treatment (active or placebo).
Time frame: Up to Day 35
Percentage of Participants With Clinically Significant Abnormal Laboratory Parameters
Blood and urine samples were collected for the analysis of laboratory parameters including clinical chemistry, hematology, and urinalysis. The investigator was responsible for reviewing laboratory results for clinically significant abnormalities.
Time frame: Up to Day 35
Percentage of Participants With Clinically Significant Changes 12-Lead Electrocardiogram (ECG) Findings
12-lead ECG recordings including heart rate and measured PR, QRS, QT, QT interval with Fridericia's correction method (QTcF) and QT interval with Bazett's correction method (QTcB) intervals. 12-lead ECG recordings were obtained after participants rested for at least 5 minutes in supine position. The investigator was responsible for reviewing laboratory results for clinically significant abnormalities.
Time frame: Up to Day 35
Percentage of Participants With Clinically Significant Abnormal Vital Signs
Vital signs including blood pressure (systolic and diastolic blood pressure), pulse rate, body temperature, respiratory rate and weight were measured after participants rested for at least 5 minutes in supine position. The investigator was responsible for reviewing laboratory results for clinically significant abnormalities.
Time frame: Up to Day 35
Change From Baseline in 2-day Average OFF Time
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SC3 Research - Pasadena
Pasadena, California, United States
Parkinson's Disease and Movement Disorders Center of Boca Raton
Boca Raton, Florida, United States
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Bradenton, Florida, United States
Premier Clinical Research Institute
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Port Charlotte, Florida, United States
Accel Research Site - Brain and Spine Institute of Port Orange
Port Orange, Florida, United States
USF Parkinson's Disease and Movement Disorders Center
Tampa, Florida, United States
Charter Research
Winter Park, Florida, United States
NeuroTrials Research, Inc.
Atlanta, Georgia, United States
...and 11 more locations
The Patient Motor Diary data (Hauser Diary) was completed by the participant to record the broad motor symptoms of pharmacodynamics. Categories included time asleep, OFF time, ON time without dyskinesia, ON time with non-troublesome dyskinesia, and ON time with troublesome dyskinesia. These diaries were collected for 24 hours on each of 2 consecutive days with records for every 30 minutes interval. The average daily OFF time was calculated from the records with reported OFF time. Baseline was defined as Day 0. Change from Baseline was defined as post Baseline minus Baseline value.
Time frame: Baseline and at Day 27