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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
138
Behavioral Research Specialists, LLC
Glendale, California, United States
CBH Health, LLC
Gaithersburg, Maryland, United States
Community Clinical Research CCR
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 \[TEAEs\].
Time frame: 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).
Time frame: 4 Week study
Key secondary - Change from baseline in clinical global impression severity of Illness [CGI-S] score
Efficacy measure by mean change from baseline top endpoint of the Clinical Global Impression Severity of Illness \[CGI-S\]: the investigator rates the severity of a subject's condition on a 7-point scale ranging from 1 (no symptoms) to 7 (very severe).
Time frame: 4 Week study
Rating at endpoint on the CGI - Change from baseline (CGI-C)
Efficacy measured by Clinical Global Impression of Change \[CGI-C\]: 7-point scale requiring the clinician to rate how much the patient's illness has improved at endpoint relative to the baseline state (score of 1, 2, 3); CGI-C ranges from 1 (very much improved) to 7 (very much worse), with a score of 4 indicating "no change".
Time frame: 4 Week study
Evaluate plasma drug concentrations over time for evenamide and its major metabolite, (3-butoxy-phenyl)-acetic acid
Determine the multiple-dose plasma concentrations of evenamide and its major metabolite, (3-butoxy-phenyl)-acetic acid, at the doses tested. Doses of evenamide to be evaluated in this study, compared to placebo, will be 7.5 mg bid, and 15 mg bid, with key information being collected at or near the time of the predicted maximal plasma concentration (Tmax) for evenamide.
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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
...and 4 more locations
Time frame: 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
Determine if the PK parameters are dose proportional. Doses of evenamide to be evaluated in this study, compared to placebo, will be 7.5 mg bid, and 15 mg bid, with key information being collected at or near the time of the predicted maximal plasma concentration (Tmax) for evenamide.
Time frame: 4 Week study
Efficacy - changes in daily functioning
Determine the effect of evenamide, compared to placebo, on daily functioning, based on changes on the Strauss-Carpenter Level of Functioning (LOF) scale; The LOF is a semi-structured, clinician-administered scale of nine items. The individual items fall into four domains, with higher scores on a 5-point scale (0 - 4) reflecting better functioning. The subscales are Social Contacts (frequency and quality of social contacts), Work (quantity and quality of useful work), Symptomatology (absence of symptoms and recent hospitalization), and Function (ability to meet basic needs, fullness of life, and overall level of function). A total score is calculated as the sum of the raw scores across the nine items.
Time frame: 4 Week study
Efficacy - rating score of patient satisfaction with the study medication
Determine the patient's satisfaction with the study medication, compared to their previous treatment, based on improvements on the Medication Satisfaction Questionnaire (MSQ) which is a single-item, 7-point Likert-type scale for patients with schizophrenia to rate their satisfaction with their antipsychotic medication. The patient's response to the question "Overall, how satisfied are you with your current antipsychotic medication(s)?" is rated by the clinician as follows: 1 = extremely dissatisfied, 2 = very dissatisfied, 3 = somewhat dissatisfied, 4 = neither satisfied nor dissatisfied, 5 = somewhat satisfied, 6 = very satisfied, and 7 = extremely satisfied
Time frame: 4 Week study