EUCTR2012-003996-20-BG进行中（未招募）不适用
A Phase 3, Multicenter, Extension of Study ALK9072-003 to Assess the Long-term Safety andDurability of Effect of ALKS 9072 in Subjects with Stable Schizophrenia - NA
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 500
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
- •Subjects Who Participated in ALK9072-003
- •1. Subject completed the ALK9072-003 Day 85 visit
- •2. Subject continues to require chronic treatment with an antipsychotic medication, in the opinion of the investigator
- •3. Subject continues to meet the contraceptive requirements of the study (see Section 7.5.1)
- •4. Subject is willing to continue, and has provided informed consent before initiation of any study specific procedures
- •New Subjects (Not Participated in ALK9072-003)
- •1. Subject is between 18 and 70 years old, inclusive, at screening
- •2. Subject is on a stable dose of oral antipsychotic medication and would potentially benefit from conversion to an extended release injectable, in the opinion of the investigator
- •3. Subject has a diagnosis of chronic schizophrenia (based on DSM-IV-TR criteria) that is clinically stable as evidenced by:
- •- No hospitalizations for acute exacerbations of schizophrenia within 3 months before
- •- CGI-S score of = 3 (mild) at screening
- •4. Subject has previously had a clinically significant beneficial response (improvement in
- •schizophrenia symptoms), as determined by the investigator, to treatment with an antipsychotic medication other than clozapine
- •5. Subject has been able to achieve outpatient status for more than 3 consecutive months in the past year
- •6. Subject has a PANSS total score of less than 70 at screening
- •7. Subject has a BMI of 18.5 to 40.0 kg/m2 (inclusive) at screening
- •8. Subject resides in a stable living situation, in the opinion of the investigator
- •9. Subject has an identified reliable informant, in the opinion of the investigator
- •10. Subject meets contraceptive requirements defined in the protocol (see Section 7.5.1)
- •11. Subject is fluent (oral and written) in the language in which standardized tests will be administered, and can be reliably rated
- •12. Subject is willing and able to provide informed consent and subject has signed the informed consent form before initiation of any study specific procedures
- •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 450
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
排除标准
- •Subjects Who Participated in ALK9072-003
- •1. Subject had an abnormal clinical laboratory, vital sign, or ECG finding during participation in
- •study ALK9072-003 that was clinically relevant and related to study drug, in the opinion of the
- •investigator
- •2. Subject was withdrawn from study ALK9072-003 due to a severe AE or a SAE, or
- •because of development of a serious medical condition or serious tolerability issues
- •3. Subject missed more than 1 scheduled study visit during participation in study ALK9072-003
- •4. Subject has a significant or unstable medical condition that would preclude safe completion of the current study
- •5. Subject requires use of a prohibited concomitant medication
- •6. Subject is pregnant or breastfeeding
- •New Subjects (Not Participated in ALK9072-003)
- •1. Subject has a history of poor or inadequate clinical response to treatment with aripiprazole
- •2. Subject has a history of treatment resistance, defined as failure to respond to 2 adequate trials of different antipsychotic medications (a minimum of 4 weeks at the subject's maximum tolerated dose)
- •3. Subject has a history of neuroleptic malignant syndrome, clinically significant tardive dyskinesia, tardive dystonia, or other medical condition that would convey undue risk or interfere with study assessments
- •4. Subject has clinically significant extrapyramidal symptoms at screening or baseline
- •5. Subject is at significant risk of suicidal, homicidal or violent ideation or behavior, by history or as clinically assessed by the investigator
- •6. Subject answers Yes” on items 4 or 5 of the C-SSRS (ideation) with the most recent episode occurring within the past 2 months, or answers Yes” to any of the 5 items (behavior) with an episode occurring within the last year
- •7. Subject has a diagnosis (according to DSM-IV-TR criteria) of substance (including alcohol)
- •dependence currently or within 6 months before screening or abuse within 3 months before
- •screening (exception: nicotine and caffeine dependence are allowed)
- •8. Subject has comorbid schizoaffective disorder, bipolar disorder, major depressive disorder,
- •dementia, delirium, amnestic or any other cognitive disorder currently or within the past 2 years
- •9. Subject has a clinically significant or unstable medical illness/condition/disorder that would be
- •anticipated, in the investigator’s opinion, to potentially compromise subject safety or adversely
- •affect the evaluation of durability of effect
- •10. Subject has clinically significant cardiac arrhythmia, cardiomyopathy, or cardiac conduction
- •defect, history of myocardial infarction or unstable angina within the last 3 months before
- •screening, or clinically significant abnormality on screening or baseline ECG including but not
- •limited to the following: QTcF > 465 msec for
- •11. Subject has a laboratory abnormality that, in the opinion of the investigator, would compromise the well-being of the subject, or any of the following laboratory abnormalities at screening or baseline:
- •? AST or ALT value = 2 times the upper limit of the laboratory normal reference range
- •? HbA1c > 9%
- •? Absolute neutrophil count ? Platelet count ? Serum creatinine > 2.5 mg/dL
- •? Positive test result for HIV, Hbs-Ag, or antihepatitis C virus antibody
- •? Urine drug screen at screening or baseline indicates illicit substance use with a positive
- •result for any of the tested substances
- •? Exception: results positive for benzodiazepines, opiates, or barbitu
研究者
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