EUCTR2020-003726-23-BG招募中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
- 招募中
- 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
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 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 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. 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 a person from the patient’s closest inner circle who knows the patient well, has been capable of interacting with the patient on daily basis, and preferably consistent throughout the study.
- •-- The study partner must interact with the subject on a daily basis. 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 not allowed if not involved in administration of any of the protocol assessments.
- •- Patients must, in the investigator’s opinion, exhibit reliability and physiologic capability (e.g. sufficient hearing, vision etc.), to comply with all protocol procedures, and have attained an educational achiev
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., stroke) or other disorders including head trauma, 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.
- •- 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)
- •- 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 randomiz
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