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
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia||Drug: CVN058 Drug: Placebos||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|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.|
|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|
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.
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.
Placebo Comparator: Placebo
- 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.
- 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
- 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).
- 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.
- 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.
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
|Contact: David H Margolin, MD, PhD||617-807-7102||David.Margolin@Cerevance.com|
|Contact: Susan Kapurchemail@example.com|
|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|
|Study Chair:||Susan Kapurch||Cerevance, Inc.|