Study to Determine the Safety, Tolerability, and Efficacy of Evenamide in Patients With Chronic Schizophrenia

NCT04461119 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: NW-3509/008/II/2019
• Study Type: interventional
• Target: 138
• Locations: 2 countries
• Sites: 14

Brief Summary

This 4-week study will evaluate the safety, tolerability and preliminary evidence of efficacy of evenamide (7.5,and 15 mg and placebo, bid) treatment in outpatients with chronic schizophrenia.

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (2)

• Safety and tolerability - incidence of Treatment-Emergent Adverse Events [TEAEs], Serious Adverse Events [AEs], and Adverse Events leading to discontinuation [ADOs]

  Comparison will be made between the evenamide and placebo groups in the proportion of patients experiencing Serious Adverse Events \[SAEs\], Adverse Events leading to discontinuation \[ADOs\] and, Treatment-Emergent Adverse Events \[TEAEs\].

  4 Week study

• Change from baseline in Positive and Negative Syndrome Scale [PANSS] total score

  Efficacy measure of mean change from baseline to endpoint of Positive and Negative Syndrome Scale \[PANSS\] total score: this is a 30-item scale that was designed to assess various symptoms of schizophrenia each rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology).

  4 Week study

Secondary Outcomes (6)

• Key secondary - Change from baseline in clinical global impression severity of Illness [CGI-S] score

  4 Week study

• Rating at endpoint on the CGI - Change from baseline (CGI-C)

  4 Week study

• Evaluate plasma drug concentrations over time for evenamide and its major metabolite, (3-butoxy-phenyl)-acetic acid

  4 Week study

• Comparison of plasma drug concentrations over time for evenamide and its major metabolite, (3-butoxy-phenyl)-acetic acid between the dosing arms 7.5 mg BID and 15.0 mg BID

  4 Week study

• Efficacy - changes in daily functioning

  4 Week study

Study Arms (3)

Evenamide 7.5 mg bid

EXPERIMENTAL

Evenamide capsules 7.5 mg BID for a total of 28 dosing days

Drug: Evenamide

Evenamide 15 mg bid

EXPERIMENTAL

Evenamide capsules 15.0 mg BID for a total of 28 dosing days

Drug: Evenamide

Placebo

PLACEBO COMPARATOR

Matching placebo capsules BID for a total of 28 dosing days

Drug: Placebo

Interventions

Evenamide DRUG

oral capsules for 4 weeks of treatment

Also known as: NW-3509

Evenamide 15 mg bid; Evenamide 7.5 mg bid

Placebo DRUG

oral capsules for 4 weeks of treatment

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Demographics
• Age - 18 years, or older
• Sex - male, or non-childbearing potential female unless practicing adequate contraception
• Psychiatric
• Has a current diagnosis of schizophrenia in accordance with DSM-5.
• Has been treated with antipsychotics for at least 2 years.
• Has a total score on the PANSS \< 80.
• Has a Clinical Global Impression - Severity of disease (CGI-S) rating of mildly, moderately or moderately severely ill (score of 3, 4 or 5).
• Needs antipsychotic treatment and is currently receiving a stable dose (minimally for 4 weeks prior to screening) of aripiprazole, clozapine, quetiapine, olanzapine, paliperidone, or risperidone (at least 2 mg risperidone dose-equivalent)
• Current symptoms have been stably present for at least one month
• Procedural
• Patient resides at home or in a residential care facility
• If taking clozapine, patient agrees to blood monitoring

You may not qualify if:

• Psychiatric
• Severity of current episode of psychosis requires that the patient be hospitalized. Patients who are chronically hospitalized or in psychiatric day-care, whose hospitalization is for logistic reasons and not due to the severity of their illness, will be eligible for the study.
• Severity of psychosis is rated severe or higher (CGI-S of 6 or greater).
• Known suicidal risk. A "yes" response on the C-SSRS Suicidal Ideation Item 4 or Item 5, or a "yes" response on any of the five C-SSRS Suicidal Behavior items, at screening, or a suicide attempt within the past 6 months, excludes the patient from the study.
• Patients with a diagnosis of Treatment resistance
• History of neuroleptic malignant syndrome, priapism.
• Current moderate or severe tardive dyskinesia.
• Medical Status
• Abnormal epileptiform phenomena (3 per second spike and slow wave discharges) observed on screening EEG. History or current diagnosis of epilepsy or seizure disorder (other than febrile seizures in childhood)
• Insulin-dependent diabetes mellitus
• History or current diagnosis of any neurodegenerative illnesses
• Loss of 500 ml or more of blood during the 3-month period before study enrollment, e.g. as a donor
• Cardiovascular
• A current diagnosis of severe or unstable cardiovascular disease
• Any clinically significant ECG abnormality

Sponsors & Collaborators

• Newron Pharmaceuticals SPA: lead

Study Sites (14)

Behavioral Research Specialists, LLC

Glendale, California, 91206, United States

Location

CBH Health, LLC

Gaithersburg, Maryland, 20877, United States

Location

Community Clinical Research CCR

Austin, Texas, 78754, United States

Location

Help Hospitals Clinical Research Department

Vijayawada, Andhra Pradesh, 520002, India

Location

St. John's Medical College Hospital

Koramangala, Karnataka, India

Location

Mangala Hospital and Mangala Kidney Foundation, Department of Psychiatry

Mangalore, Karnataka, India

Location

IQRAA Psychiatry Care and Rehabilitation Centre

Kozhikode, Kerala, India

Location

Deenanath Mangeshkar Hospital Research Center

Pune, Maharashtra, India

Location

Sujata Birla Hospital

Pune, Maharashtra, India

Location

Post Graduate Institute of Medical Education and Research

Chandigarh, Punjab, 160012, India

Location

Dayanand Medical College & Hospital

Ludhiana, Punjab, India

Location

Sri Ramachandra Medical College, Department of Psychiatry

Chennai, Tamil Nadu, 600116, India

Location

Ahana Hospital LLP

Madurai, Tamil Nadu, India

Location

Asha Hospital

Hyderabad, Telangana, 500034, India

Location

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Ravi Anand, MD

  Newron Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2020
• First Posted: July 8, 2020
• Study Start: June 16, 2020
• Primary Completion: February 20, 2021
• Study Completion: March 13, 2021
• Last Updated: May 20, 2021

Record last verified: 2021-05

Locations

IN (11); US (3)