EUCTR2020-003744-84-HR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 BI 425809 once daily over 26 week treatment period in patients with schizophrenia (CONNEX-2)
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. Signed and dated written informed consent in accordance with International Council on Harmonisation for Good Clinical Practice (ICH-GCP) and local legislation prior to 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 staying focused, difficulties remembering 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.
- •-- Doses should be within the recommended dose range listed in the approved product labelling of the country where the study is being conducted. 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 should be within the recommended dose range listed in the approved product labelling of the country where the study is being conducted.
- •Further criteria apply.
- •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 586
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
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.
- •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 (ie. 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.
- •8. Patients who were treated with any of the following within 6 months prior to randomization:
- •-- Clozapine
- •-- Stimulants (e.g. methylphenidate, dextroamphetamine, modafinil)
- •-- Ketamine
- •-- Electroconvulsive therapy (ECT) or modified ECT
- •Further criteria apply.
研究者
相似试验
进行中（未招募）
1 期
A study investigating the safety of radium-223 dichloride with abiraterone acetate and prednisone/prednisolone given to patients with castration-resistant prostate cancer that has spread to bone, and who never had chemotherapy before.Asymptomatic or mildly symptomatic chemotherapy-naïve bone predominant metastatic castration-resistant prostate cancerMedDRA version: 21.1Level: PTClassification code 10036909Term: Prostate cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2013-003438-33-SEBayer AG806
进行中（未招募）
1 期
Clinical trial of Iclepertin (BI 425809) effect on cognition and functional capacity in schizophrenia.schizophreniaEUCTR2020-003760-11-NOBoehringer Ingelheim Norway KS586
进行中（未招募）
1 期
Clinical trial of iclepertin effect on cognition and functional capacity in schizophrenia.schizophreniaEUCTR2020-003726-23-DKBoehringer Ingelheim B.V.586
进行中（未招募）
1 期
Clinical trial of iclepertin effect on cognition and functional capacity in schizophrenia.MedDRA version: 20.0Level: PTClassification code 10039626Term: SchizophreniaSystem Organ Class: 10037175 - Psychiatric disordersschizophreniaEUCTR2020-003726-23-DEBoehringer Ingelheim Pharma GmbH & Co. KG586
进行中（未招募）
1 期
Clinical trial of iclepertin effect on cognition and functional capacity in schizophrenia.MedDRA version: 20.0Level: PTClassification code 10039626Term: SchizophreniaSystem Organ Class: 10037175 - Psychiatric disordersschizophreniaEUCTR2020-003726-23-FIBoehringer Ingelheim Finland Ky586