Status:
COMPLETED
Study to Determine the Safety, Tolerability, and Efficacy of Evenamide in Patients With Chronic Schizophrenia
Lead Sponsor:
Newron Pharmaceuticals SPA
Conditions:
Schizophrenia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 evena...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 16 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 13 2021
Estimated Enrollment :
138 Patients enrolled
Trial Details
Trial ID
NCT04461119
Start Date
June 16 2020
End Date
March 13 2021
Last Update
May 20 2021
Active Locations (14)
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1
Behavioral Research Specialists, LLC
Glendale, California, United States, 91206
2
CBH Health, LLC
Gaithersburg, Maryland, United States, 20877
3
Community Clinical Research CCR
Austin, Texas, United States, 78754
4
Help Hospitals Clinical Research Department
Vijayawada, Andhra Pradesh, India, 520002