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

NCT ID: NCT04461119

Last Updated: 2021-05-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 138 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-16
• Study Completion Date: 2021-03-13

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.

Detailed Description

This is a prospective, 4-week, randomized, double-blind, placebo-controlled, study designed to evaluate the safety, tolerability, EEG effects, and preliminary efficacy of two fixed oral doses of evenamide of 7.5 mg and 15 mg bid (15 and 30 mg/day) in outpatients with chronic schizophrenia who are receiving treatment at constant doses of one of the following atypical antipsychotics: aripiprazole, clozapine, quetiapine, olanzapine, paliperidone or risperidone. Approximately 120 patients will be randomized in a 1:1:1 ratio to receive either evenamide 7.5 or 15 mg, or placebo, given bid.

Conditions

Schizophrenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Evenamide 7.5 mg bid

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

Group Type: EXPERIMENTAL

Evenamide

Intervention Type: DRUG

oral capsules for 4 weeks of treatment

Evenamide 15 mg bid

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

Group Type: EXPERIMENTAL

Evenamide

Intervention Type: DRUG

oral capsules for 4 weeks of treatment

Placebo

Matching placebo capsules BID for a total of 28 dosing days

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

oral capsules for 4 weeks of treatment

Interventions

Evenamide

oral capsules for 4 weeks of treatment

Intervention Type: DRUG

Placebo

oral capsules for 4 weeks of treatment

Intervention Type: DRUG

Other Intervention Names

NW-3509

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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
• Abnormal vital signs

Laboratory abnormalities

• Clinically significant abnormalities in routine laboratory examinations
• History and/or presence of hepatitis B and/or C
• Positive results from the HIV serology.
• Positive results of the drug and alcohol tests
• Clinically significant or unstable hypothyroidism or hyperthyroidism

Concomitant therapy

• Treatment with SSRIs that are moderate/potent inhibitors of CYP2D6 (e.g. fluoxetine)
• Treatment with drugs capable of inducing/inhibiting hepatic enzyme metabolism
• Current treatment with sodium channel blockers
• Exposure to any investigational drug within 5 weeks or 5 half-lives (whichever is longer) prior to screening
• A known exaggerated pharmacological sensitivity or hypersensitivity to drugs similar to evenamide (e.g. lamotrigine, carbamazepine, oxcarbazepine, topiramate, etc.), or any components of the evenamide or matching placebo capsules
• Treatment with a drug or treatment known to cause major organ system toxicity, e.g. tamoxifen, within 4 weeks, or received radiation therapy or a drug with cytotoxic potential, e.g. chemotherapy, during the past year
• Electroconvulsive therapy (ECT) or treatment with a transcranial magnetic stimulation (TMS) device within 6 months prior to screening

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Newron Pharmaceuticals SPA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ravi Anand, MD

Role: STUDY_DIRECTOR

Newron Pharmaceuticals

Locations

Behavioral Research Specialists, LLC

Glendale, California, United States

CBH Health, LLC

Gaithersburg, Maryland, United States

Community Clinical Research CCR

Austin, Texas, United States

Help Hospitals Clinical Research Department

Vijayawada, Andhra Pradesh, India

St. John's Medical College Hospital

Koramangala, Karnataka, India

Mangala Hospital and Mangala Kidney Foundation, Department of Psychiatry

Mangalore, Karnataka, India

IQRAA Psychiatry Care and Rehabilitation Centre

Kozhikode, Kerala, India

Deenanath Mangeshkar Hospital Research Center

Pune, Maharashtra, India

Sujata Birla Hospital

Pune, Maharashtra, India

Post Graduate Institute of Medical Education and Research

Chandigarh, Punjab, India

Dayanand Medical College & Hospital

Ludhiana, Punjab, India

Sri Ramachandra Medical College, Department of Psychiatry

Chennai, Tamil Nadu, India

Ahana Hospital LLP

Madurai, Tamil Nadu, India

Asha Hospital

Hyderabad, Telangana, India

Countries

United States; India

Other Identifiers

NW-3509/008/II/2019

Identifier Type: -

Identifier Source: org_study_id