EUCTR2020-003760-11-DE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 (BI 425809) once daily over 26 week treatment period in patients with schizophrenia (CONNEX-1) - Iclepertin (BI425809) Pivotal efficacy study 1
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
- •-- Outpatient, clinically stable and in the residual (non-acute) phase of
- •their illness.
- •-- No hospitalization or increase in level of psychiatric care 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
- •XML File Identifier: VafcXcRxbylp+rj09d+z+IB01KE=
- •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.
- •-- Switch from 1-month to 3-monthinjectable formulation of same
- •antipsychotic during the 12 weeks prior to randomization is allowed, but
- •not with in last 35 days prior to randomization.
- •-- 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 lorazepamequivalent
- •Table of relevant medications and their equivalencies will be
- •provided as a part of ISF.
- •-- For any other psychoactive medications, doses cannot exceed the
- •maximum 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
- 另有 7 项未显示
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
- •2. Cognitive impairment due to developmental, neurological (e.g.,
- •epilepsy, stroke) or other disorders including head trauma, or patients
- •XML File Identifier: VafcXcRxbylp+rj09d+z+IB01KE=
- •with dementia.
- •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 nopsychoactive
- •drug trial, prior to randomization.
- •- Patients who were previously treated with Iclepertin
- •- 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 (when used for the treatment of epilepsy)
- •-- Tricyclic antidepressants
- •-- Traditional Chinese medicine/ non-Western therapy
- •-- Medical devices therapy (e.g. TMS, neurofeedback)
- 另有 13 项未显示
研究者
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