A Phase IIa, prospective, randomized, double-blind, placebo-controlled, multiple-dose study designed to determine the safety, tolerability and preliminary efficacy of an oral dose range of NW-3509A in patients with chronic schizophrenia not responding adequately to their current antipsychotic medication.

ewron Pharmaceuticals SpA0 sites0 target enrollmentStarted: TBDLast updated: November 24, 2021

Trial Snapshot

Phase: Phase 2
Status: Recruiting
Sponsor

Study Overview Eligibility Criteria Investigators Records & Identifiers Similar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type: Interventional

Eligibility Criteria

Inclusion Criteria

•1. Age - 18 to 65 years, inclusive.
•2. Sex â?? male, or female not of childbearing potential.
•3. Body weight of at least 45 kg for females and 55 kg for males
•4. Has a current diagnosis of schizophrenia in accordance with DSM-5. Other Axis-I disorders may be present only as lifetime diagnoses if they are not relevant to the current episode of schizophrenia.
•5. Schizophrenia was diagnosed at least 2 years ago.
•6. Has a total score on the PANSS <80.
•7. Has a CGI-S rating of mildly, moderately or moderately severely ill (score of 3, 4 or 5).
•8. Is in need of anti-psychotic treatment and is currently receiving a stable dose (minimally for 4 weeks prior to screening) of oral risperidone or aripiprazole (at least 2 mg risperidone dose-equivalent).
•9. Current symptoms present for at least one month.
•10. Patient is cooperative, able to take oral medication, willing to complete all aspects of the study, and capable of doing so.
•11. Patient is residing at home or in a residential care facility with a caregiver available to ensure compliance with dosing and scheduled office visits.
•12. Patient is able to understand the instructions and fully participate.
•13. Patient has provided written informed consent prior to participating in the study.
•14. Patient agrees to be hospitalized for up to 2 days at the start of dosing, and at each subsequent dose level increase, and when the investigator deems it necessary to ensure the safety of the patient.

Exclusion Criteria

•1. DSM-5 diagnosis of schizophreniform disorder (295.40), schizoaffective disorder (295.70), or other primary psychiatric diagnosis, such as bipolar disorder or major depressive disorder (depression will be assessed at screening and baseline using the CDSS; a score of >=6 will be exclusionary)
•2. History (within 3 months of study entry) or current diagnosis of Substance Use Disorder as defined by the DSM-5 criteria, with a severity of â??moderateâ?? or â??severeâ??, or patient is currently abusing drugs or alcohol or has done so in the past year. A history of nicotine dependence is acceptable
•3. Severity of psychosis rated severe or higher (CGI-S of 6 or greater)
•4. Has a rating of 5 (moderately severe) or higher on any of the following symptoms on the PANSS or has a rating of 4 (moderate) on more than two of these items.
•5. History or current diagnosis of other psychiatric (Axis I diagnosis), or behavioral disorders that may interfere with the conduct or interpretation of the study
•6. Known suicidal risk. A â??yesâ?? response on the C-SSRS Suicidal Ideation Item 4 or Item 5, or a â??yesâ?? response on any of the five C-SSRS Suicidal Behavior items, at screening, or a suicide attempt within the past 6 months, would exclude the patient from the study
•7. â??Treatment resistantâ??, defined as lack of any significant symptomatic relief after adequate doses of two standard antipsychotic medications (from two different chemical classes, including at least one atypical antipsychotic) for 6 weeks of treatment each
•8. History of neuroleptic malignant syndrome
•9. Current evidence of moderate or severe tardive dyskinesia.
•10. An advanced, severe, or unstable disease of any type that may interfere with any of the study evaluations, including any medical condition that could be expected to progress, recur, or change to such an extent that it may bias the assessment of the clinical or mental status of the patient to a significant degree or put the patient at special risk (e.g., liver or kidney disease; malignancy)
•11. A disability that may prevent the subject from completing all study requirements (e.g., blindness, deafness, severe language difficulty)
•12. A current diagnosis of active, uncontrolled peptic ulceration within the last year
•13. A current diagnosis of acute, severe, or unstable asthmatic condition
•14. Insulin-dependent diabetes mellitus. Patients with non-insulin-dependent diabetes will be eligible if the following criteria are satisfied
•a. HbA1c < 7.0% at screening,
•b. Diabetes is considered well controlled, with no changes in treatment regimen for at least 4 weeks prior to screening,
•c. Diabetes is not newly diagnosed at screening;
•15. History or current diagnosis of any neurodegenerative illness, dementia or significant concomitant neurological disease
•16. History or current diagnosis of epilepsy or seizure disorder (other than febrile seizures in childhood)
•17. Organic cerebral disease, cerebrovascular disease, focal neurological lesions or history of any trauma resulting in loss of consciousness (during the past 2 years)
•18. Loss of 500 ml or more of blood during the 3-month period before the study, e.g. as a donor.
•19. Prior surgery or current medical condition which might interfere with the absorption, distribution, metabolism or excretion of the study drug, e.g. gastric or

Investigators

Sponsor

ewron Pharmaceuticals SpA

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