EUCTR2020-003726-23-CZ进行中（未招募）1 期
A phase III randomized, double-blind, placebo-controlled parallel group trial to examine the efficacy and safety of Iclepertin once daily over 26 week treatment period in patients with schizophrenia (CONNEX-3)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 586
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. Patients must be capable of providing signed and dated written informed consent by date of Visit 1 in accordance with ICH Harmonized Tripartite Guideline for Good Clinical Practice (ICH-GCP) and the local legislation prior to the admission to the trial.
- •2. Male or female patients who are 18-50 years (inclusive) of age at time of consent.
- •3. Diagnosis of schizophrenia utilizing DSM-5 with the following clinical features:
- •-- Outpatient, clinically stable and in the residual (non-acute) phase of their illness.
- •-- No hospitalization1 or increase in level of psychiatric care2 due to worsening of schizophrenia within 12 weeks prior to randomization.
- •-- PANSS score: items P1, P3-P6 = 5 and item P2 and P7 = 4 at Visit 1, and confirmed at Visit 2.
- •4. Patients should have functional impairment in day-to-day activities such as difficulties following conversation or expressing themselves, difficulties to stay focused, difficulties to remember instructions, what to say or how to get to places, per investigator judgement.
- •5. Patients maintained on current antipsychotic treatment (minimum 1 and maximum 2 antipsychotics, but clozapine is not allowed) for at least 12 weeks and on current dose for at least 35 days prior to randomization.
- •-- For patients on two antipsychotics, at least one antipsychotic must be within the approved label dose range. The second antipsychotic must not
- •exceed the maximum daily dose per local label
- •-- Note: If the total dose is stable, different dosage forms of the same antipsychotic treatment will be considered as one antipsychotic.
- •6. Patients with any other concomitant psychoactive medications (except for anticholinergics) need to be maintained on same drug for at least 12 weeks and on current dose/ regimen for at least 35 days prior to randomization.
- •-- Maximum daily benzodiazepine load of up to 1 mg lorazepam-equivalent and
- •hypnotic load up to 0.25 mg brotizolam-equivalent as needed (pro re nata, prn). Table of relevant medications and their equivalencies will be provided as a part of ISF
- •-- For any other psychoactive medications, doses cannot exceed the maxium daily dose per local label.
- •- Women of childbearing potential (WOCBP)5 must be ready and able to use highly effective methods of birth control per Non-Clinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals (ICH M3 (R2)) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria is provided in Section 4.2.2.3. Such methods should be used throughout the trial, and for a period of at least 35 days after last trial drug intake, and the patient must agree to periodic pregnancy testing during participation in the trial.
- •- Have a study partner, defined as any person either private or professional who knows the patient well, has been capable of interacting with the patient on regular basis, and preferably consistent throughout the study.
- •-- The study partner must interact with the subject a minimum 1 hour per week and, preferably, at least 2 times a week. At least one interaction per week should be in person.
- •-- The study partner must have educational achievement of minimum 8th grade.
- •-- Professional study partners (e.g. study nurse, social worker etc.) are allowed if not involved in administration of any of the protocol assessments.
- •- Patients must, in the investigator’s opinion, exhibit reliability and physiologic capa
排除标准
- •1. Participant with current DSM-5 diagnosis other than Schizophrenia, including but not limited to bipolar, schizoaffective, major depressive disorder etc. M.I.N.I. for Psychotic disorders should be used for guidance.
- •2. Cognitive impairment due to developmental, neurological (e.g., epilepsy, stroke) or other disorders including head trauma, or patients with dementia or epilepsy
- •3. Severe movement disorders
- •-- Leading to cognitive impairment (e.g. Parkinson dementia), or
- •-- Interfering with the efficacy assessments, or
- •-- Due to antipsychotic treatment that cannot be controlled with low dose anticholinergic treatment (equal to maximum 1 mg benztropine twice daily). Table of relevant medications and their equivalencies will be provided as a part of ISF
- •4. Any suicidal behavior in the past 1-year prior to screening and during the screening period.
- •5. Suicidal ideation of type 5 in the C-SSRS (i.e. active suicidal thought with plan and intent)
- •in the past 3 months prior to screening and up to and including Visit 2.
- •-- Patients with Suicidal Ideation type 4 in the C-SSRS (i.e. active suicidal thought with intent but without specific plan), within 3 months prior to screening and up to and including Visit 2, can be randomized in the study, if assessed and documented by a licensed mental health professional that there is no immediate risk of suicide.
- •6. History of moderate or severe substance use disorder (other than caffeine and nicotine), as defined in DSM-5 within the last 12 months prior to informed consent.
- •7. Positive urine drug screen at Visit 1 based on central lab test. For a list of drugs assessed in the urine drug screen
- •8. Patients who were treated with any of the following within 6 months prior to randomization:
- •-- Clozapine
- •-- Stimulants (e.g. methylphenidate, dextroamphetamine, modafinil)
- •-- Ketamine or esketamine
- •-- Electroconvulsive therapy (ECT) or Modified ECT
- •- Participation in any investigational psychoactive drug trial (both industry/ academic) in last 6 months, and 30 days or 5 half-lives for no-psychoactive drug trial, prior to randomization.
- •- Previous participation in any BI 425809 study.
- •- Patients who are treated with any of the following within the last 35 days prior to randomization:
- •-- Strong or moderate CYP3A4 inhibitors including grapefruit juice
- •-- Strong or moderate CYP3A4 inducers including St. John’s wort (Hypericum perforatum)
- •-- Dietary supplements and herbal remedies that may impact cognition, in the investigator´s judgement
- •-- Antiepileptics
- •-- Tricyclic antidepressants
- •-- Traditional Chinese medicine/ non-Western therapy
- •-- Medical devices therapy (e.g. TMS, neurofeedback)
- •- Patients who plan to change their current life-style habits including but not limited to alcohol, nicotine or caffeine use, or diet, during the treatment period.
- •- Patients who have participated in a clinical trial with repeated assessments (i.e. a single assessment is not exclusionary) with the MCCB and/ or any other schizophrenia cognitive battery within 12 weeks prior to screening.
- •- Any formal Cognitive Remediation Therapy (CRT) within 12 weeks prior to screening. Initiation of CRT is not allowed during the study.
- •- Initiation or change in any type or frequency of psychotherapy (e.g. cognitive behavioral therapy, social skills training, vocational/occupational therapy) within 12 weeks prior to randomization. Patients with ongoing, stable psychotherapy for more than 12 weeks prior to randomization (and intend to maintain the s
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