Back to resultsCVN058 Effect on Mismatch Negativity in Schizophrenics
Primary Purpose
Schizophrenia
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
CVN058
Placebos
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring MMN, EEG, P50, gamma power, P300, auditory gating
Eligibility Criteria
Inclusion Criteria:
- Subjects 18 to 50 years of age, inclusive, at the time of informed consent.
- The subject weighs at least 50 kg and has a body mass index (BMI) between 18 and 40 kg/m2 inclusive at Screening.
- Subject meets schizophrenia criteria as defined by the Diagnostic & Statistical Manual of mental Disorders, 5th Edition (DSM-V).
- Subjects are on a stable dose of antipsychotic medication(s) for at least 2 months prior to - Screening as documented by medical history and assessed by site staff.
- Subject has a Positive and Negative Syndrome Scale (PANSS) total score of <95.
Exclusion Criteria:
- Subject currently receiving treatment with any excluded medication or dietary supplement.
- Subjects who have a history of gastrointestinal disease that would influence the absorption of study drug or have a history of any surgical intervention known to impact absorption (e.g., bariatric surgery or bowel resection).
- Subjects having clinical laboratory evaluations (including clinical chemistry, hematology and complete urinalysis) outside the reference range for the testing laboratory, unless the results are deemed to be not clinically significant (NCS) by the investigator at Screening.
- Subjects with moderate to severe substance use disorder, unstable mood or anxiety disorder.
- Subject has a current diagnosis of a significant psychiatric illness other than schizophrenia per DSM-V and is in an acute phase/episode.
- Subject has clinically meaningful hearing loss.
Sites / Locations
- Icahn School of Medicine at Mount Sinai
- New York State Psychiatric Institute
- Nathan Kline Institute
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
CVN058, low dose
CVN058, high dose
Placebo
Arm Description
CVN058 prepared in concentrations of 10mg/mL, and are compounded by the clinical site. Subjects will receive one dose of CVN058 at 15mg or 75mg substitution of 15mg.
CVN058 prepared in concentrations of 10mg/mL, and are compounded by the clinical site. Subjects will receive one dose of CVN058 at 150mg.
Matching placebo.
Outcomes
Primary Outcome Measures
Quantitative Electroencephalogram, Mismatch Negativity (MMN)
Mean amplitude of duration MMN following administration of CVN058 compared to placebo.
Secondary Outcome Measures
Evaluation of adverse events
Occurrence of all adverse events from signing of informed consent through end of study treatment
Full Information
NCT ID
NCT03669250
First Posted
September 4, 2018
Last Updated
August 4, 2022
Sponsor
Cerevance Alpha, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT03669250
Brief Title
CVN058 Effect on Mismatch Negativity in Schizophrenics
Official Title
A Placebo-Controlled Study to Evaluate the Effect of a Single Dose of CVN058 on Mismatch Negativity in Subjects With Stable Schizophrenia
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
November 9, 2018 (Actual)
Primary Completion Date
March 6, 2020 (Actual)
Study Completion Date
March 6, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cerevance Alpha, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a phase 1, double-blind, placebo-controlled, 3 period cross-over study to evaluate CVN058 target engagement by measuring auditory evoked potential mismatch negativity (MMN) downstream to 5-hydroxytryptamine receptor 3 (5-HT3) as a pharmacodynamic (PD) marker.
Detailed Description
Male and female subjects with schizophrenia, age 18 to 50 years old, inclusive, will be randomized to 1 of 6 treatment sequences (Table 2.a) to receive 1 of 3 dose regimens in each period: a single oral administration of CVN058 (15 mg or 150 mg) or matching placebo. The sequence will determine the order in which a subject will take each of the 3 regimens. Discontinued subjects may be replaced at the discretion of the sponsor so that approximately 20 completed subjects are available for analysis.
The study includes three 1-day treatment periods, with a minimum of 7-day washout, maximum 10 day washout (2 total washouts, after Periods 1 and 2) between periods, and a 7-10 day follow-up call post dosing of the last period. Subjects may be inpatients or outpatients at the discretion of the Investigator.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
MMN, EEG, P50, gamma power, P300, auditory gating
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Model Description
Male and female subjects with schizophrenia, age 18 to 50 years old, inclusive, will be randomized to 1 of 6 treatment sequences to receive 1 of 3 dose regimens in each period; a single oral administration of CVN058, or a matching placebo.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Double blind, placebo controlled.
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CVN058, low dose
Arm Type
Active Comparator
Arm Description
CVN058 prepared in concentrations of 10mg/mL, and are compounded by the clinical site. Subjects will receive one dose of CVN058 at 15mg or 75mg substitution of 15mg.
Arm Title
CVN058, high dose
Arm Type
Active Comparator
Arm Description
CVN058 prepared in concentrations of 10mg/mL, and are compounded by the clinical site. Subjects will receive one dose of CVN058 at 150mg.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Matching placebo.
Intervention Type
Drug
Intervention Name(s)
CVN058
Intervention Description
3-way crossover
Intervention Type
Drug
Intervention Name(s)
Placebos
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Quantitative Electroencephalogram, Mismatch Negativity (MMN)
Description
Mean amplitude of duration MMN following administration of CVN058 compared to placebo.
Time Frame
1.5 hours post-dose on Day 1
Secondary Outcome Measure Information:
Title
Evaluation of adverse events
Description
Occurrence of all adverse events from signing of informed consent through end of study treatment
Time Frame
Screening through 30 days post-dose.
Other Pre-specified Outcome Measures:
Title
Quantitative Electroencephalogram, Gamma Power
Description
EEG measurements of delta (0.5 - 4 Hz), theta (4-7 Hz), alpha (8-13 Hz), delta (13-20 Hz), low gamma (20-40 Hz) and high gamma (40 - 60 Hz).
Time Frame
1.5 hours post-dose on Day 1
Title
Quantitative Electroencephalogram, P300
Description
EEG measurement of peak amplitude within prespecified latency range at the frontal/parietal sites.
Time Frame
1.5 hours post-dose on Day 1
Title
Quantitative Electroencephalogram, P50
Description
EEG measurement of stimulus signal of 90-dB pulses of 0.1 msec in duration.
Time Frame
1.5 hours post-dose on Day 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects 18 to 50 years of age, inclusive, at the time of informed consent.
The subject weighs at least 50 kg and has a body mass index (BMI) between 18 and 40 kg/m2 inclusive at Screening.
Subject meets schizophrenia criteria as defined by the Diagnostic & Statistical Manual of mental Disorders, 5th Edition (DSM-V).
Subjects are on a stable dose of antipsychotic medication(s) for at least 2 months prior to - Screening as documented by medical history and assessed by site staff.
Subject has a Positive and Negative Syndrome Scale (PANSS) total score of <95.
Exclusion Criteria:
Subject currently receiving treatment with any excluded medication or dietary supplement.
Subjects who have a history of gastrointestinal disease that would influence the absorption of study drug or have a history of any surgical intervention known to impact absorption (e.g., bariatric surgery or bowel resection).
Subjects having clinical laboratory evaluations (including clinical chemistry, hematology and complete urinalysis) outside the reference range for the testing laboratory, unless the results are deemed to be not clinically significant (NCS) by the investigator at Screening.
Subjects with moderate to severe substance use disorder, unstable mood or anxiety disorder.
Subject has a current diagnosis of a significant psychiatric illness other than schizophrenia per DSM-V and is in an acute phase/episode.
Subject has clinically meaningful hearing loss.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan Kapurch
Organizational Affiliation
Cerevance, Inc.
Official's Role
Study Chair
Facility Information:
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
New York State Psychiatric Institute
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Nathan Kline Institute
City
New York
State/Province
New York
ZIP/Postal Code
10962
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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CVN058 Effect on Mismatch Negativity in Schizophrenics
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