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

NCT04191577 | Completed Phase 2 Results FDA Drug

• 1 other identifier: CVN424-201
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 21

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.

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

• 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).

  Up to Day 35

Secondary Outcomes (4)

• Percentage of Participants With Clinically Significant Abnormal Laboratory Parameters

  Up to Day 35

• Percentage of Participants With Clinically Significant Changes 12-Lead Electrocardiogram (ECG) Findings

  Up to Day 35

• Percentage of Participants With Clinically Significant Abnormal Vital Signs

  Up to Day 35

• Change From Baseline in 2-day Average OFF Time

  Baseline and at Day 27

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Placebo to be administered once daily.

Drug: Placebo

CVN424 (Low Dose)

ACTIVE COMPARATOR

Low dose of CVN424 to be administered once daily.

Drug: CVN424 Low Dose

CVN424 (High Dose)

ACTIVE COMPARATOR

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

Interventions

CVN424 Low Dose DRUG

CVN424

Also known as: CVN424

CVN424 (Low Dose)

CVN424 High Dose DRUG

CVN424

Also known as: CVN424

CVN424 (High Dose)

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Cerevance Beta, Inc.: lead

Study Sites (21)

Collaborative Neuroscience Network, LLC

Long Beach, California, 90806, United States

Location

SC3 Research - Pasadena

Pasadena, California, 91105, United States

Location

Parkinson's Disease and Movement Disorders Center of Boca Raton

Boca Raton, Florida, 33486, United States

Location

Nova Clinical Research

Bradenton, Florida, 34209, United States

Location

Premier Clinical Research Institute

Miami, Florida, 33122, United States

Location

Parkinson's Disease Treatment Center of SW Florida

Port Charlotte, Florida, 33980, United States

Location

Accel Research Site - Brain and Spine Institute of Port Orange

Port Orange, Florida, 32127, United States

Location

USF Parkinson's Disease and Movement Disorders Center

Tampa, Florida, 33613, United States

Location

Charter Research

Winter Park, Florida, 32792, United States

Location

NeuroTrials Research, Inc.

Atlanta, Georgia, 30328, United States

Location

Parkinson's Disease and Movement Disorder Center

Kansas City, Kansas, 66160, United States

Location

Boston Clinical Trials

Roslindale, Massachusetts, 02131, United States

Location

Quest Research Institute

Farmington Hills, Michigan, 48334, United States

Location

Bio Behavioral Health

Toms River, New Jersey, 08755, United States

Location

New York Neurology Associates

New York, New York, 10003, United States

Location

M3 Wake Research

Raleigh, North Carolina, 27612, United States

Location

Optimed Research Ltd

Columbus, Ohio, 43235, United States

Location

Neurology Diagnostics Inc

Dayton, Ohio, 45459, United States

Location

Prisma Health

Greenville, South Carolina, 29615, United States

Location

Central Texas Neurology Consultants

Round Rock, Texas, 78681, United States

Location

Inland Northwest Research, LLC

Spokane, Washington, 99202, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Results Point of Contact

• Title: Michelle Charles, Executive Director Regulatory Affairs
• Organization: Cerevance

michelle.charles@cerevance.com

(408) 220-5722

Study Officials

• Susan Kapurch

  Cerevance, Inc.

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 30, 2019
• First Posted: December 10, 2019
• Study Start: December 2, 2019
• Primary Completion: November 6, 2021
• Study Completion: December 13, 2021
• Last Updated: July 3, 2024
• Results First Posted: July 3, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (21)