CVN058 Effect on Mismatch Negativity in Schizophrenics
|ClinicalTrials.gov Identifier: NCT03669250|
Recruitment Status : Active, not recruiting
First Posted : September 13, 2018
Last Update Posted : July 27, 2020
|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|
|Actual Primary Completion Date :||May 1, 2020|
|Estimated Study Completion Date :||August 30, 2020|
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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03669250
|United States, New York|
|Icahn School of Medicine at Mount Sinai|
|New York, New York, United States, 10029|
|New York State Psychiatric Institute|
|New York, New York, United States, 10032|
|Nathan Kline Institute|
|New York, New York, United States, 10962|
|Study Chair:||Susan Kapurch||Cerevance, Inc.|