Phase 1
Completed N=22
CVN058 Effect on Mismatch Negativity in Schizophrenics
Source: ClinicalTrials.gov NCT03669250 ↗Enrolled (actual)
22
Serious AEs
0.0%
Results posted
Oct 2024
Primary outcomePrimary: Mean Amplitude of Duration of Auditory Mismatch Negativity (MMN) by Dose Level — -0.551; -0.749; -0.386; -1.084 microvolts
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Amplitude of Duration of Auditory Mismatch Negativity (MMN) by Dose Level |
-0.551; -0.749; -0.386; -1.084 | — |
| SECONDARY Number of Participants Reporting Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) |
1; 1; 1; 4; 0; 0 | — |
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.
Data sourced from ClinicalTrials.gov (NCT03669250). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.