EUCTR2020-000437-41-IT进行中（未招募）1 期
A pilot, open-label, rater-blinded, randomized, parallel-group, multi-center study to evaluate the safety, tolerability and preliminary efficacy of three add-on fixed doses of Evenamide in patients with treatment-resistant schizophrenia (TRS) not responding adequately to their stable, therapeutically active dose of a single antipsychotic medication - NW-3509/014/II/2019
EWRON PHARMACEUTICALS SPA0 个研究点目标入组 150 人开始时间: 2020年10月21日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 150
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Age - 18 years, or older.
- •2. Sex – male, or female not of childbearing potential, unless using adequate
- •contraception, as determined by their Health Care Provider.
- •3. Meets current DSM-5 criteria for schizophrenia. Other psychiatric disorders may be
- •present only as lifetime diagnoses if they are not relevant to the current episode of
- •schizophrenia. [see Exclusion criteria below]
- •4. Has been diagnosed with schizophrenia within the past 10 years.
- •5. Has shown treatment-resistance according to psychiatric history, with the last failed
- •treatment documented in the patient’s clinical records. Treatment-resistant
- •Schizophrenia” (TRS) is defined as a persistence of significant clinical symptoms
- •despite adequate doses of two standard antipsychotic medications (other than clozapine)
- •from two different chemical classes, including at least one atypical antipsychotic, for
- •at least 6 weeks of treatment each. The last failed treatment trial must be documented.
- •6. Has a Clinical Global Impression – Severity of disease (CGI-S) rating of moderately
- •ill to severely ill (score of 4 to 6 [scale 1-7]).
- •7. Has a PANSS total score = 70 at screening and baseline.
- •8. Has a score of 4 (moderate) or more on at least 2 of the following 4 PANSS symptoms
- •of psychosis: P2 (Conceptual Disorganization), P3 (Hallucinatory Behavior), P6
- •(Suspiciousness/Persecution) and G9 (Unusual Thought Content); and a total score of at
- •least 20 on the combined total of the PANSS symptom items: P1 (Delusions), P2
- •(Conceptual Disorganization), P3 (Hallucinatory Behavior), P4 (Excitement), P6
- •(Suspiciousness/Persecution), P7 (Hostility), and G9 (Unusual thought content).
- •9. Has a Global Assessment of Functioning (GAF) scale total score = 50.
- •10. Is in need of anti-psychotic treatment and is currently receiving mono-therapy at a
- •stable dose (minimally for 4 weeks prior to screening) at a minimal recommended
- •therapeutic or higher dose of one antipsychotic (atypical or typical, other than
- •clozapine). Current use of quetiapine at a dose of 150 mg or less at night as a
- •soporific will not be considered polypharmacy.
- •11. Current level of symptoms has been present for at least one month, but not exceeding
- •12. Patient is cooperative, able to take oral medication, able to understand the
- •instructions and willing to complete all aspects of the study, and is capable of doing
- •13. Patient is residing with a caregiver at his/her home, or is either in a residential
- •care facility or residing alone, with a caregiver available to help ensure compliance
- •with dosing and scheduled office visits in either situation.
- •14. Patient has provided written informed consent prior to participating in the study.
- •15. Patient agrees to be hospitalized overnight if required for trial purposes or if the investigator deems it necessary to ensure the safety of the patient.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 143
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 7
排除标准
- •1. DSM-5 diagnosis of schizophreniform disorder, schizoaffective disorder, or other primary psychiatric diagnosis
- •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
- •3. Severity of current episode of psychosis requires that the patient be hospitalized
- •4. Has a PANSS total score > 90 or a CGI-S rating of 7
- •5. History or current diagnosis of other psychiatric or behavioral disorders
- •6. Known suicidal risk, or a suicide attempt within the past 2 years
- •7. History of neuroleptic malignant syndrome, priapism or moderate or severe tardive dyskinesia
- •8. An advanced, severe, or unstable disease of any type that may interfere with any of the study evaluations
- •9. Insulin-dependent diabetes mellitus
- •10. History or current diagnosis of any neurodegenerative illness, dementia, significant concomitant neurological disease, organic cerebral disease, cerebrovascular disease, focal neurological lesions or history of any trauma resulting in loss of consciousness (during the past 2 years)
- •11. History or current diagnosis of epilepsy or seizure disorder, or occurrence of a seizure within the past year, or repeated drug-induced seizures
- •12. Prior surgery or current medical condition which might interfere with the absorption, distribution, metabolism or excretion of the study drug
- •13. Any clinically significant ECG abnormality, including a disorder of rate, rhythm, or conduction, or other morphological changes, or a QTcF interval prolongation
- •14. Vital signs outside the following ranges:
- •a.Systolic blood pressure < 90 or > 150 mmHg;
- •b.Diastolic blood pressure < 50 or > 95 mmHg;
- •c.Radial pulse (from vital signs) < 50 or > 100 bpm;
- •d.Orthostatic hypotension
- •15. History of hepatitis B and/or C, and/or positive serology results, which indicate the presence of hepatitis B and/or C
- •16. Positive results from the HIV serology
- •17. Positive results of the drug and alcohol tests at screening and/or baseline
- •18. History of or current treatment with clozapine for psychosis
- •19. Requires treatment with an anticholinergic drug, and the dose is not stable
- •20. Receiving benzodiazepine therapy, unless the dose has been stabilized for at least 2 months
- •21. Treatment with agents influencing dopamine, norepinephrine or serotonin neurotransmission
- •22. Treatment with drugs capable of inducing/inhibiting hepatic enzyme metabolism (e.g. barbiturates, carbamazepine, phenylbutazone, phenytoin, primidone, rifampicin) four weeks prior to baseline or during the study
- •23. Current treatment with sodium channel blockers or mood stabilizers; Valproic acid will be permitted, if used as maintenance treatment
- •24. Exposure to any investigational drug within 5 weeks or 5 half-lives prior to screening
- •25. A known exaggerated pharmacological sensitivity or hypersensitivity to drugs similar to evenamide, or any components of the evenamide capsules
- •26. Electroconvulsive therapy (ECT) or treatment with a transcranial magnetic stimulation (TMS) device within 6 months prior to screening
- •27. Patient is female and of childbearing potential, pregnant or breastfeeding. For inclusion, female patients must be post-menopausal, surgically sterilized, or using adequate contraception
- •28. Patients with a reasonable likelihood of non-compliance with the protocol, or any other reason that, in the Investigat
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