CVN058 Effect on Mismatch Negativity in Schizophrenics

Schizophrenia Clinical Trial

Official title:

A Placebo-Controlled Study to Evaluate the Effect of a Single Dose of CVN058 on Mismatch Negativity in Subjects With Stable Schizophrenia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03669250
• Other study ID #: CVN058-103
• Status: Completed
• Phase: Phase 1
• Start date: November 9, 2018
• Est. completion date: March 6, 2020

Study information

• Verified date: August 2022
• Source: Cerevance
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 6, 2020
• Est. primary completion date: March 6, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• CVN058
3-way crossover
• Placebos
Placebo

Locations

Country	Name	City	State
United States	Icahn School of Medicine at Mount Sinai	New York	New York
United States	Nathan Kline Institute	New York	New York
United States	New York State Psychiatric Institute	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Cerevance Alpha, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Quantitative Electroencephalogram, Gamma Power	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).	1.5 hours post-dose on Day 1
Other	Quantitative Electroencephalogram, P300	EEG measurement of peak amplitude within prespecified latency range at the frontal/parietal sites.	1.5 hours post-dose on Day 1
Other	Quantitative Electroencephalogram, P50	EEG measurement of stimulus signal of 90-dB pulses of 0.1 msec in duration.	1.5 hours post-dose on Day 1
Primary	Quantitative Electroencephalogram, Mismatch Negativity (MMN)	Mean amplitude of duration MMN following administration of CVN058 compared to placebo.	1.5 hours post-dose on Day 1
Secondary	Evaluation of adverse events	Occurrence of all adverse events from signing of informed consent through end of study treatment	Screening through 30 days post-dose.