CTRI/2020/02/023099已完成2 期
A Phase II, prospective, multi-center, randomized, 4-week, double-blind, placebo-controlled, multiple-dose study, designed to determine the safety, tolerability, EEG effects and preliminary efficacy of fixed oral doses of 7.5 and 15 mg bid of evenamide (NW-3509) in patients with chronic schizophrenia who are symptomatic on their current second-generation antipsychotic (aripiprazole, clozapine, quetiapine, olanzapine, paliperidone, or risperidone) medication.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 13
- 主要终点
- To evaluate the safety and tolerability (including EEG and ECG effects) of two fixed oral doses of evenamide (7.5 and 15 mg bid [15 and 30 mg/day]), compared to placebo, in patients with schizophrenia who are being treated with stable doses of antipsychotic medication (aripiprazole, clozapine, quetiapine, olanzapine, paliperidone or risperidone).
研究概览
简要总结
This is a prospective, 4-week, randomized, double-blind, placebo-controlled, study designed to evaluate the safety, tolerability, including effects on EEG recordings, and preliminary efficacy of two fixed oral doses of evenamide of 7.5 mg and 15 mg bid (15 and 30 mg/day) in patients 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. Immediately following completion of the 4-week double-blind phase, participants may enter a 48-week open-label extension study (Study NW-3509/009/II/2019) in which all patients will receive treatment with evenamide.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Double Blind Double Dummy
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Psychiatric 4.Has a current diagnosis of schizophrenia in accordance with DSM-
- •Other Axis-I disorders may be present only as lifetime diagnoses if they are not relevant to the current episode of schizophrenia.
- •[see Exclusion criteria below] 5.Has been treated with antipsychotics for at least 2 years.
- •6.Has a total score on the PANSS <
- •7.Has a Clinical Global Impression – Severity of disease (CGI-S) rating of mildly, moderately or moderately severely ill (score of 3, 4 or 5).
- •8.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).
- •9.Current symptoms have been stably present for at least one month.
- •Procedural 10.Patient has provided written informed consent prior to participating in the study.
- •11.Patient is able to take oral medication and is willing to complete all protocol-defined aspects of the study.
- •12.Patient resides at home or in a residential care facility with a caregiver who is available to ensure compliance with dosing and scheduled office visits.
- •For US only: “Caregiver†is defined as someone who has at least 5 contacts with the patient each week, of which at least 2 are face-to-face.
- •14.If taking clozapine, patient agrees to blood monitoring (venipuncture for measuring ANC) weekly during their first 6 months of clozapine treatment, every 2 weeks from 6 to 12 months, and every 4 weeks after 12 months of treatment.
排除标准
- •Psychiatric 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.
- •(Comorbid depression will be assessed at screening and baseline using the Calgary Depression Scale for Schizophrenia [CDSS].
- •A score of 7 or higher will be exclusionary.) 2.History (within three months of study entry) or current diagnosis of Substance Use Disorder as defined by the DSM-5 criteria, with a severity of ‘moderate’ or ‘severe’, or patient is currently abusing drugs or alcohol or has done so in the past year.
- •A history of nicotine or caffeine dependence is acceptable 3.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.
- •4.Severity of psychosis is rated severe or higher (CGI-S of 6 or greater).
- •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 “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.
- •7.“Treatment resistant†defined significant persistent symptoms of schizophrenia after adequate doses of two standard antipsychotic medications (from two different chemical classes, including at least one atypical antipsychotic) following 6 weeks of treatment with each at adequate doses.
- •Treatment resistant patients on clozapine for at least 6 months will be permitted if they have shown minimal improvement in the Investigator’s judgement.
- •8.History of neuroleptic malignant syndrome, priapism.
- •9.History of severe tardive dyskinesia; or current moderate or severe tardive dyskinesia.
- •Medical Status 10.Abnormal epileptiform phenomena (3 per second spike and slow wave discharges) observed on screening EEG.
- •11.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., respiratory, liver or kidney disease; malignancy); 12.A disability that may prevent the subject from completing all study requirements (e.g., blindness, deafness, severe language difficulty); 13.Insulin-dependent diabetes mellitus.
- •Patients with non-insulin-dependent diabetes will be eligible if the following criteria are satisfied:.
结局指标
主要结局
To evaluate the safety and tolerability (including EEG and ECG effects) of two fixed oral doses of evenamide (7.5 and 15 mg bid [15 and 30 mg/day]), compared to placebo, in patients with schizophrenia who are being treated with stable doses of antipsychotic medication (aripiprazole, clozapine, quetiapine, olanzapine, paliperidone or risperidone).
时间窗: 28 Days
次要结局
- To evaluate evidence for efficacy of evenamide in a range from 7.5 to 15 mg bid, compared to placebo, based on improvements in symptoms of schizophrenia, as assessed by the Positive and Negative Syndrome Scale (PANSS) and Clinical Global Impression - Change from baseline (CGI-C) and Severity of illness (CGI-S)(4 Weeks)
研究者
研究点 (13)
Loading locations...
相似试验
已完成
2 期
A Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial of Bavituximab Plus Docetaxel in patients with Previously Treated Locally Advanced or Metastatic Non-Squamous Non Small Cell Lung Cancer.CTRI/2010/091/001403Peregrine Pharmaceuticals Inc Franklin Avenue Suite Tustin CA USA120
撤回
2 期
A Study of ACI-24 in Adults With Down SyndromeDown SyndromeNCT04373616AC Immune SA
终止
2 期
Study of EYP001a to Assess Its Safety and Anti-viral Effect in CHB Patients in Combination With NA (ETV or TD)Hepatitis B, ChronicNCT04465916Enyo Pharma26
进行中（未招募）
2 期
Phase II Study to Evaluate Efficacy and Safety of AMP Peptide PL-5 in Mild Infections of Diabetic Foot UlcersDiabetic Foot UlcersNCT06189638Jiangsu ProteLight Pharmaceutical & Biotechnology Co., Ltd.90
已完成
2 期
A Study of RO4917838 (Bitopertin) in Patients With Acute Exacerbation of SchizophreniaSchizophreniaNCT01234779Hoffmann-La Roche301