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CVN058 Effect on Mismatch Negativity in Schizophrenics

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ClinicalTrials.gov Identifier: NCT03669250
Recruitment Status : Recruiting
First Posted : September 13, 2018
Last Update Posted : August 26, 2019
Sponsor:
Information provided by (Responsible Party):
Cerevance Alpha, Inc.

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.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: CVN058 Drug: Placebos Phase 1

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention 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: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Double blind, placebo controlled.
Primary Purpose: Treatment
Official Title: A Placebo-Controlled Study to Evaluate the Effect of a Single Dose of CVN058 on Mismatch Negativity in Subjects With Stable Schizophrenia
Actual Study Start Date : November 9, 2018
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Active Comparator: CVN058, 15 mg
CVN058 prepared in concentrations of 10mg/mL, and are compounded by the clinical site. Subjects will receive one dose of CVN058 at 15mg.
Drug: CVN058
3-way crossover

Active Comparator: CVN058, 150 mg
CVN058 prepared in concentrations of 10mg/mL, and are compounded by the clinical site. Subjects will receive one dose of CVN058 at 150mg.
Drug: CVN058
3-way crossover

Placebo Comparator: Placebo
Matching placebo.
Drug: Placebos
Placebo




Primary Outcome Measures :
  1. Quantitative Electroencephalogram, Mismatch Negativity (MMN) [ Time Frame: 1.5 hours post-dose on Day 1 ]
    Mean amplitude of duration MMN following administration of CVN058 compared to placebo.


Secondary Outcome Measures :
  1. Evaluation of adverse events [ Time Frame: Screening through 30 days post-dose. ]
    Occurrence of all adverse events from signing of informed consent through end of study treatment


Other Outcome Measures:
  1. Quantitative Electroencephalogram, Gamma Power [ Time Frame: 1.5 hours post-dose on Day 1 ]
    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).

  2. Quantitative Electroencephalogram, P300 [ Time Frame: 1.5 hours post-dose on Day 1 ]
    EEG measurement of peak amplitude within prespecified latency range at the frontal/parietal sites.

  3. Quantitative Electroencephalogram, P50 [ Time Frame: 1.5 hours post-dose on Day 1 ]
    EEG measurement of stimulus signal of 90-dB pulses of 0.1 msec in duration.



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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): NCT03669250


Contacts
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Contact: David H Margolin, MD, PhD 617-807-7102 David.Margolin@Cerevance.com
Contact: Susan Kapurch 617-916-8936 susan.kapurch@cerevance.com

Locations
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United States, New York
Icahn School of Medicine at Mount Sinai Recruiting
New York, New York, United States, 10029
Contact: Riaz Shaik    212-241-0241      
Principal Investigator: Muhammad Parvaz, PhD         
New York State Psychiatric Institute Recruiting
New York, New York, United States, 10032
Contact: Daniel C Javitt, MD, PhD         
Nathan Kline Institute Recruiting
New York, New York, United States, 10962
Contact: Josh Kantrowitz, MD         
Sponsors and Collaborators
Cerevance Alpha, Inc.
Investigators
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Study Chair: Susan Kapurch Cerevance, Inc.

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Responsible Party: Cerevance Alpha, Inc.
ClinicalTrials.gov Identifier: NCT03669250     History of Changes
Other Study ID Numbers: CVN058-103
First Posted: September 13, 2018    Key Record Dates
Last Update Posted: August 26, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Cerevance Alpha, Inc.:
MMN
EEG
P50
gamma power
P300
auditory gating
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders