Study of CVN424 in Parkinson's Disease Patients With Motor Fluctuations

Sponsor

Cerevance Beta, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT04191577

Collaborator

(none)

141

Enrollment

Locations

Arms

24.4

Actual Duration (Months)

6.7

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Parkinson Disease	Drug: CVN424 Low Dose Drug: CVN424 High Dose Drug: Placebo	Phase 2

Detailed Description

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 Design

Study Type:

Interventional

Actual Enrollment :

141 participants

Allocation:

Randomized

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.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)

Primary Purpose:

Treatment

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 :

Dec 2, 2019

Actual Primary Completion Date :

Nov 6, 2021

Actual Study Completion Date :

Dec 13, 2021

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo Placebo to be administered once daily.	Drug: Placebo Placebo
Active Comparator: CVN424 (Low Dose) Low dose of CVN424 to be administered once daily.	Drug: CVN424 Low Dose CVN424
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 CVN424

Arm

Intervention/Treatment

Placebo Comparator: Placebo

Placebo to be administered once daily.

Drug: Placebo

Placebo

Active Comparator: CVN424 (Low Dose)

Low dose of CVN424 to be administered once daily.

Drug: CVN424 Low Dose

CVN424

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

CVN424

Outcome Measures

Primary Outcome Measures

Number of Subjects who experience Adverse Events related to study drug [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).

Secondary Outcome Measures

Number of subjects with abnormal and clinically significant (CS) safety laboratory test results, ECG test results, or vital sign measurements [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 [Baseline through Day 27]
Completion of the patient motor diary over the two days prior to each visit.

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Male or female adult who is 30 to 80 years of age inclusive at study entry.
Has idiopathic Parkinson's disease, Hoehn and Yahr stages 2-4, and is on a stable dosage of levodopa.
Experiences an average of at least 2 h total OFF time/day, and at least 1 h each day, per Patient Motor Diary over 2 days during Screening assessment.
The subject signs and dates a written informed consent form (ICF) and any required privacy authorization prior to the initiation of any study procedures.

Exclusion Criteria:

Has atypical parkinsonism, severe disabling dyskinesia, or severe motor fluctuations that the investigator considers likely to interfere with study participation or assessments, or history of implant for Deep Brain Stimulation.
Poor concordance (<75%) of self-report with site rater on in-clinic Screening period Patient Motor Diary. Subjects with low concordance may be retested after further instruction, at investigator's discretion.
Screening period Patient Motor Diary scored at-home over 2 days demonstrates unacceptable quality of the diary, with more than 4 errors per day. (Assistance from caregivers is permitted if they also will be providing assistance with home Patient Motor Diary entries for Day 15 and 27 efficacy assessments.) Subjects with more than 4 errors per day may be retested after further instruction, at investigator's discretion.
Body mass index (BMI) at Screening <18.0 or >35.0 kg/m2, inclusive.
Subject has evidence of Clinically significant neurologic or other disorder or impairment that, in opinion of Investigator, is reasonably expected to impact the ability of the subject to participate or to confound the study results.
Subject has current or recent (within 6 months) gastrointestinal disease that would be expected to influence the absorption of drugs (i.e., a history of malabsorption, any surgical intervention known to impact absorption [e.g., bariatric surgery or bowel resection]).
Subject has a history of cancer or other malignancy, with the exception of low-grade cervical intraepithelial neoplasia, low-grade (low-risk) prostate cancer, or 5-year cancer-free survivors of basal or squamous cell carcinoma, higher-grade cervical intraepithelial neoplasia or prostate cancer.
Has a history of human immunodeficiency virus (HIV) infection.
Subject has a supine blood pressure outside the ranges of 80 to 160 mm Hg for systolic and 50 to 100 mm Hg for diastolic, confirmed with up to two repeat tests, at the Screening Visit; or symptomatic orthostatic hypotension, in the opinion of the investigator.
Subject has a resting heart rate outside the range 50 to 100 bpm, confirmed with up to two repeat tests, at the Screening Visit.
Positive urine result for illegal drugs (except cannabis) at Screening, or history of illegal drug use (except cannabis) or alcohol abuse within 1 year prior to the Screening Visit.
Subject has received any investigational compound (defined as a drug that has not been FDA-approved) within 30 days prior to the first dose of study medication, or within 5 half-lives of the investigational compound, whichever is greater.
Subject has, within the prior month, ingested any excluded medication, supplements, or food products listed in the Excluded Medications and Dietary Products table as listed in Table 2.
Male subjects who do not agree to all the following rules: when sexually active with female partner(s) of childbearing potential during the study and for 12 weeks after the last dose of study drug: a) use an acceptable method of birth control (condom with spermicide or surgical sterilization) and b) refrain from sexual activity with female partners who do not use an acceptable method of birth control. Barrier contraception (condom with spermicide) must be used by all male subjects who were not surgically sterilized at least 90 days prior to screening. Male subjects must also agree to refrain from sperm donation during the study and until 12 weeks after the last dose of study drug.
Female subjects who are pregnant or breastfeeding or plan to become pregnant or donate ova during the study or for 30 days after the last dose of study drug. Women of childbearing potential (WOCBP) also must be practicing an adequate method of birth control (e.g., oral or parenteral contraceptives, intrauterine device, barrier, abstinence).
Risk of suicide according to the investigator's clinical judgment or has made a suicide attempt in the previous 3 years.
Subject is a study site employee or an immediate family member of a study site employee

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Collaborative Neuroscience Network, LLC	Long Beach	California	United States	90806
2	SC3 Research - Pasadena	Pasadena	California	United States	91105
3	Parkinson's Disease and Movement Disorders Center of Boca Raton	Boca Raton	Florida	United States	33486
4	Nova Clinical Research	Bradenton	Florida	United States	34209
5	Premier Clinical Research Institute	Miami	Florida	United States	33122
6	Parkinson's Disease Treatment Center of SW Florida	Port Charlotte	Florida	United States	33980
7	Accel Research Site - Brain and Spine Institute of Port Orange	Port Orange	Florida	United States	32127
8	USF Parkinson's Disease and Movement Disorders Center	Tampa	Florida	United States	33613
9	Charter Research	Winter Park	Florida	United States	32792
10	NeuroTrials Research, Inc.	Atlanta	Georgia	United States	30328
11	Parkinson's Disease and Movement Disorder Center	Kansas City	Kansas	United States	66160
12	Boston Clinical Trials	Roslindale	Massachusetts	United States	02131
13	Quest Research Institute	Farmington Hills	Michigan	United States	48334
14	Bio Behavioral Health	Toms River	New Jersey	United States	08755
15	New York Neurology Associates	New York	New York	United States	10003
16	M3 Wake Research	Raleigh	North Carolina	United States	27612
17	Optimed Research Ltd	Columbus	Ohio	United States	43235
18	Neurology Diagnostics Inc	Dayton	Ohio	United States	45459
19	Prisma Health	Greenville	South Carolina	United States	29615
20	Central Texas Neurology Consultants	Round Rock	Texas	United States	78681
21	Inland Northwest Research, LLC	Spokane	Washington	United States	99202

Sponsors and Collaborators

Cerevance Beta, Inc.

Investigators

Study Chair: Susan Kapurch, Cerevance, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Cerevance Beta, Inc.

ClinicalTrials.gov Identifier:

NCT04191577

Other Study ID Numbers:

CVN424-201

First Posted:

Dec 10, 2019

Last Update Posted:

Aug 8, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Parkinson Disease

Study Results

No Results Posted as of Aug 8, 2022