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)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 609
- 试验地点
- 110
- 主要终点
- Change From Baseline in Overall Composite T-score of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) After 26 Weeks of Treatment
研究概览
简要总结
This study is open to adults with schizophrenia. Schizophrenia can affect the way a person thinks, their memory and their mental functioning. Examples include struggling to remember things, or to read a book or pay attention to a movie. Some people have difficulty calculating the right change or planning a trip so that they arrive on time. The purpose of this study is to find out whether a medicine called iclepertin improves learning and memory in people with schizophrenia.
Participants are put into two groups randomly, which means by chance. One group takes iclepertin tablets and the other group takes placebo tablets. Placebo tablets look like iclepertin tablets but do not contain any medicine. Participants take a tablet once a day for 26 weeks. In addition, all participants take their normal medication for schizophrenia.
During this time, doctors regularly test learning and memory of the participants by use of questionnaires, interviews, and computer tests. The results of the mental ability tests are compared between the groups.
Participants are in the study for about 8 months and visit the study site about 14 times. During this time, doctors regularly check participants' health and take note of any unwanted effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed and dated written informed consent.
- •Male or female patients who are 18-50 years (inclusive) of age at time of consent.
- •Diagnosis of schizophrenia utilizing Diagnostic and Statistical Manual of Mental Disorders 5th Edition (DSM-5).
- •-- Patients must be clinically stable and in the residual (non-acute) phase of their illness with no hospitalization or increase level of care due to worsening of schizophrenia in the past 12 weeks or no uncontrolled positive symptoms.
- •Patients should have functional impairment in day-to-day activities per investigator judgement.
- •Patients maintained on current antipsychotic treatment for at least 12 weeks and on current dose for at least 35 days prior to randomization.
- •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.
- •Women of childbearing potential must use highly effective methods of birth control.
- •Have a study partner who interacts with the patient on a regular basis. Further inclusion criteria apply.
排除标准
- •Patient with current DSM-5 diagnosis other than Schizophrenia.
- •Cognitive impairment due to other causes, or patients with dementia or epilepsy.
- •Severe movement disorders.
- •Any suicidal behavior in past year or suicidal ideation in the past 3 months.
- •History of moderate or severe substance use disorder within the last 12 months prior to informed consent.
- •Positive urine drug screen.
- •Patients who were treated with Clozapine, stimulants, ketamine or electroconvulsive therapy within 6 months prior to randomization.
- •Current participation in any investigational drug trial.
- •Cognitive Remediation Therapy within 12 weeks prior to screening.
- •Initiation or change in any type or frequency of psychotherapy within 12 weeks prior to randomization.
- •Any clinically significant finding or condition that would jeopardize the patient´s safety while participating in the trial or their capability to participate in the trial.
- •Haemoglobin (Hb) below lower limit of normal .
- •History of haemolytic anaemia, red blood cell (RBC) membrane diseases, known Glucose-6-phosphate dehydrogenase deficiency, anaemia of any cause or patients planning to donate blood.
- •Severe renal impairment.
- •Indication of liver disease.
- •Any documented active or suspected malignancy or history of malignancy within 5 years.
- •Women who are pregnant, nursing, or who plan to become pregnant while in the trial.
- •Further exclusion criteria apply.
研究组 & 干预措施
Iclepertin 10 mg
Patients with schizophrenia took one tablet of 10 milligram (mg) iclepertin orally once daily for 26 weeks. Patients were permitted to remain on other antipsychotic and psychotropic medications, as specified in the eligibility criteria.
干预措施: Iclepertin (Drug)
Placebo
Patients with schizophrenia took one tablet of placebo matching iclepertin orally once daily for 26 weeks. Patients were permitted to remain on other antipsychotic and psychotropic medications, as specified in the eligibility criteria.
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in Overall Composite T-score of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) After 26 Weeks of Treatment
时间窗: The MMRM model incorporates values from baseline (Week 0), Week 12 and Week 26. The data represent the Least Squares Means at Week 26.
The MCCB assesses 7 cognitive domains, including speed of processing, attention vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. T-scores in the general population have a mean of 50 and standard deviation of 10, and a higher score indicates better cognition. The primary analysis was a restricted maximum likelihood (REML) based approach using a mixed-effects model for repeated measurements (MMRM), which included the fixed categorical effects of treatment at each visit, fixed categorical effect of the stratification factor using the screening MCCB overall composite T-score, and a fixed effect for the continuous covariate of baseline at each visit. Visit was treated as the repeated measure with an unstructured covariance structure used to model the within-subject dependencies. Intercurrent events were addressed using different pre-defined strategies.
次要结局
- Change From Baseline in the Schizophrenia Cognition Rating Scale (SCoRS) Interviewer Total Score After 26 Weeks of Treatment(The MMRM model incorporates values from baseline (Week 0), Week 12 and Week 26. The data represent the Least Squares Means at Week 26.)
- Change From Baseline to Week 26 in the Adjusted Total Time T-score in Virtual Reality Functional Capacity Assessment Tool (VRFCAT)(The MMRM model incorporates values from baseline (Week 0), Week 12 and Week 26. The data represent the Least Squares Means at Week 26.)
- Change From Baseline to Week 26 in the T-score of the Number of Correct Responses on Tower of London(At baseline (Week 0) and at Week 26.)
- Change From Screening Visit 1a to Week 24 in Patient Reported Experience of Cognitive Impairment in Schizophrenia (PRECIS) Total Score(The MMRM model incorporates values from baseline (screening), Week 15 and Week 24. The data represent the Least Squares Means at Week 24.)
- Ocular Safety Sub-study: Change From Baseline in Humphrey Visual Field 24-2 Swedish Interactive Thresholding Algorithm (SITA) Standard at Week 24(Measurements were performed at baseline (screening) and at Week 24.)
- Ocular Safety Sub-study: Change From Baseline in Spectral Domain Ocular Coherence Tomography (OCT)(Measurements were performed at baseline (screening) and at Week 24.)