EUCTR2017-004439-36-RO进行中（未招募）1 期
A 52-Week Open-Label Extension Study of Pimavanserin in Adult and Elderly Subjects With Neuropsychiatric Symptoms Related to Neurodegenerative Disease
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 300
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. Subject satisfied all entry criteria for the antecedent pimavanserin study
- •2. The subject may benefit from longer term therapy with open-label pimavanserin treatment in the judgment of the Investigator
- •3. Subject completed the antecedent study; or was participating in a pimavanserin study that the Sponsor ended early
- •4. Has a designated study partner/caregiver who meets the following requirements:
- •a. In the Investigator’s opinion, is in contact with the subject frequently enough to accurately report on the
- •subject’s symptoms and whether or not the subject is taking the study drug
- •b. In the Investigator’s opinion, is considered reliable in providing support to the subject to help ensure
- •compliance with study treatment, study visits, and protocol procedures
- •c. Is fluent in the local language in which study assessments will be administered
- •d. Agrees to participate in study assessments, has the capacity to provide informed consent, and provides
- •written consent to participate in the study
- •5. Subject can come to the clinic for study visits with a study partner/caregiver
- •6. Subject is willing and able to provide informed consent. Consent for the present study must be obtained prior to the final procedures being performed at antecedent study’s EOT visit or ET visit (if the study was ended early by the Sponsor). If the subject is deemed not competent to provide informed consent, the following requirements for consent must be met:
- •a. The subject’s legally acceptable representative (LAR) (or study partner/caregiver, if local regulations allow) must provide written informed consent
- •b. The subject must provide written (if capable) informed assent
- •7. If the subject is female, she must not be pregnant or breastfeeding. She must also be of non-childbearing
- •potential (defined as either surgically sterilized or at least 1 year postmenopausal) or must agree to use a clinically acceptable method of contraception or be abstinent during the study and 1 month following completion of the study.
- •Abstinence as a method of contraception is defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. This option is usually made for a specific moral, religious, legal, or health reason. If heterosexual intercourse does occur, an acceptable method of birth control is required.
- •Acceptable methods of birth control include the following:
- •a. Condom, diaphragm, or cervical cap with spermicide
- •b. Hormonal contraception, including oral, injectable, transdermal, or implantable methods
- •c. Intrauterine device (IUD)
- •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 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 270
排除标准
- •1. Subject is judged by the Investigator or the Medical Monitor to be inappropriate for the study, due to AEs,
- •medical condition, or noncompliance with investigational product or study procedures in the antecedent study, or is judged to be a danger to self or others
- •2. Is in hospice, is receiving end-of-life palliative care, or has become bedridden
- •3. Has any of the following ECG results at the EOT/ET visit of the antecedent study:
- •a. If the subject is not on citalopram, escitalopram, or venlafaxine:
- •i. QTcF >450 ms, if QRS duration <120 ms
- •ii. QTcF >470 ms, if QRS duration =120 ms
- •b. If the subject is on citalopram, escitalopram, or venlafaxine:
- •i. QTcF >425 ms, if QRS duration <120 ms
- •ii. QTcF >450 ms, if QRS duration =120 ms
- •4. Has a heart rate <50 beats per minute. If bradycardia is secondary to iatrogenic or treatable causes and these causes are treated, a heart rate assessment can be repeated at the EOT/ET visit of the antecedent study
- •5. Has a body mass index (BMI) <18.5 kg/m2 or known unintentional clinically significant weight loss (i.e., =7% of body weight) over past 6 months
- •6. Has clinically significant laboratory abnormalities in the antecedent study that, in the judgment of the Investigator or Medical Monitor, would either:
- •a. jeopardize the safe participation of the subject in the study; OR
- •b. would interfere with the conduct or interpretation of safety or efficacy evaluations in the study
- •7. Is suicidal as defined below at Visit 1 (Baseline) of the ACP-103-047 study:
- •a. If the subject was assessed in the antecedent study using the Columbia-Suicide Severity Rating Scale
- •(C-SSRS), he or she must not be actively suicidal at Visit 1 (Baseline) (including an answer of yes” to
- •C-SSRS questions 4 or 5) and must not have attempted suicide (using the Since Last Visit”
- •version) prior to Visit 1 (Baseline) of the present study; OR
- •b. If the subject is not able to reliably complete the C-SSRS in the Investigator’s judgment or if the
- •Global Clinician Assessment of Suicidality (GCAS) scale was used in the antecedent study, the subject
- •must not be suicidal as assessed by the GCAS score (i.e., a score of 3 or 4) based on Investigator’s
- •assessment of behavior since-last-visit at Visit 1 (Baseline); OR
- •c. The subject is actively suicidal in the Investigator’s judgment
- •8. Has developed a neurologic, cardiovascular, respiratory, gastrointestinal, renal, hepatic, hematologic, or other medical or mental disorder, including cancer or malignancies that, in the judgment of the Investigator,
- •would increase the risk associated with taking study medication or significantly interfere with the conduct or
- •interpretation of the study
- •9. Requires treatment with a medication or other substance that is prohibited by the protocol
- •10. Has a significant sensitivity or allergic reaction to pimavanserin or its excipients
- •11. Is an employee of ACADIA, or has a family member who is an employee of ACADIA
研究者
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