Study of CVN424 in Parkinson's Disease Patients With Motor Fluctuations
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|ClinicalTrials.gov Identifier: NCT04191577|
Recruitment Status : Completed
First Posted : December 10, 2019
Last Update Posted : August 8, 2022
|Condition or disease||Intervention/treatment||Phase|
|Parkinson Disease||Drug: CVN424 Low Dose Drug: CVN424 High Dose Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||141 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Planned dose levels are placebo, low dose, and high dose of CVN424. Study drug dispensed as CVN424 suspension (or matching placebo) in amber glass bottles suitable for self-administered dosing.|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Phase II, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of CVN424 in Parkinson's Disease Patients With Motor Fluctuations|
|Actual Study Start Date :||December 2, 2019|
|Actual Primary Completion Date :||November 6, 2021|
|Actual Study Completion Date :||December 13, 2021|
Placebo Comparator: Placebo
Placebo to be administered once daily.
Active Comparator: CVN424 (Low Dose)
Low dose of CVN424 to be administered once daily.
Drug: CVN424 Low Dose
Active Comparator: CVN424 (High Dose)
Patients randomized to the high dose will receive low-dose CVN424 once daily from day 1 to day 7, and will then increase their dose to the full high-dose once daily beginning on day 8.
Drug: CVN424 High Dose
- Number of Subjects who experience Adverse Events related to study drug [ Time Frame: Baseline through 30 days after the last dose ]AEs with onset or exacerbation up until dosing on Day 1 will be scored as pretreatment events (PTEs), and AEs that occur from first dosing until 30 days after the last dose will be captured as a treatment-emergent AE (TEAE).
- Number of subjects with abnormal and clinically significant (CS) safety laboratory test results, ECG test results, or vital sign measurements [ Time Frame: Baseline through Day 27 ]Twelve-lead ECGs will be recorded using an ECG machine that automatically calculates the heart rate and measures PR interval, RR interval, QRS interval, QT interval, and QTcF and QTcB (Fridericia's and Bazett's correction method) intervals. Observed values and changes from baseline in quantitative ECG parameters will be summarized by placebo, and each CVN424 dose level.
- Change from baseline in 2-day average OFF time at Day 27 as recorded in the Patient Motor Diary [ Time Frame: Baseline through Day 27 ]Completion of the patient motor diary over the two days prior to each visit.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04191577
|Study Chair:||Susan Kapurch||Cerevance, Inc.|