EUCTR2021-005388-32-HU进行中（未招募）1 期
A 52-Week Open-Label Extension Study of Pimavanserin in Children and Adolescents with Irritability Associated with Autism Spectrum Disorder (ASD)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 228
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
- •Study Population
- •1. Has completed the treatment period of the antecedent double-blind study.
- •2. Informed consent prior to the conduct of any study procedures is required as follows:
- •a. The subject should provide written or oral assent if deemed able by the Investigator.
- •b. The subject’s parent/LAR must provide written consent. The subject’s parent/LAR must be considered reliable by the Investigator, able to complete assessments regarding the subject's development and behavior throughout the study, and able to help ensure compliance with study treatment, study visits, and protocol procedures.
- •c. If a person other than the parent/LAR has been designated as a caregiver for the purpose of providing input for caregiver-reported scales, that person must also provide written consent. Such a designee should be a family member, adult and responsible, living with or in very frequent contact with the subject participating in the study, who is committed to providing responses for the caregiver-reported scales for the duration of the study.
- •The process of obtaining informed consent will be conducted in accordance with institutional review board (IRB) or ethics committee (EC) policy and applicable local law.
- •3. In the Investigator’s opinion, the subject, to the best of his/her ability, the parent/LAR, and the designated caregiver (if applicable, and in accordance with IRB or EC policy and applicable local law) are able to understand the nature of the study, follow protocol requirements and be willing to comply with study drug administration requirements.
- •Psychiatric Diagnosis
- •4. Continues to be both clinically stable and not at imminent risk of suicide or injury to self, others, or property, in the opinion of the Investigator.
- •5. Continues to be medically stable at enrollment, in the opinion of the Investigator.
- •Contraceptives
- •6. Female subjects who participate in this study must either be unable to become pregnant (e.g., premenarchal, surgically sterile, etc.) -OR- must agree to use two clinically acceptable methods of contraception (e.g., oral, intrauterine device [IUD], diaphragm plus spermicide, injectable, transdermal or implantable contraception) during the treatment period, and for at least 45 days after last dose. All female subjects of childbearing potential must have a negative urine human chorionic gonadotropin (hCG) pregnancy test at Baseline and all clinic visits.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 228
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Study Population
- •1. Subject or parent/LAR is judged by the Investigator to be inappropriate for the study (e.g., significantly noncompliant in the antecedent double-blind study).
- •CNS, Psychiatric, and Illicit Drug Use Criteria
- •2. Requires treatment with a medication prohibited by the protocol, including concomitant psychotropic drugs targeting irritability, including those used off-label (clonidine, guanfacine, and propranolol; lithium, valproate; stimulant and non-stimulant medications), medications that prolong the QT interval; and strong cytochrome P450 (CYP) 3A4 enzyme (CYP3A4) inhibitors and inducers.
- •3. Is at a significant risk of suicide, or is a danger to self or others, in the opinion of the Investigator based upon all available sources of information including C-SSRS (positive answer to suicidal ideation questions 4 or 5 [or positive answer to suicidal behavior questions at Baseline]).
- •4. Is at risk of significant violent behavior to the extent that participation would pose an undue risk to other patients, caregivers, or others in the opinion of the Investigator.
- •5. Has a positive urine drug test at Baseline. For study eligibility, the urine toxicology (drug) screen (UDS) must be negative for any substance for which the subject does not have a valid prescription.
- •Medical Criteria
- •6. Has developed a serious and/or unstable psychiatric, neurologic, cardiovascular (e.g., long QT syndrome, torsade de pointes, unstable cardiac syndrome or syncope, congestive heart failure, ongoing uncorrected hypokalemia or hypomagnesemia, non-sustained or sustained ventricular tachycardia), respiratory, gastrointestinal, renal, hepatic, hematologic, or other medical disorder, including cancer or malignancies that, in the judgment of the Investigator, would jeopardize the safe participation of the subject in the study, or has major surgery planned during the study.
- •7. Has experienced any change in medical or treatment status that may increase the risk associated with taking pimavanserin, would interfere with safety assessments, or would confound the interpretation of study results, based on the Investigator’s judgment.
- •8. For age <13 years, a resting position (sitting or supine) systolic (SBP) and/or diastolic blood pressure (DBP) level =90th percentile for gender-specific age and height charts
- •from the National Heart and Lung Institute (NHLI), at Baseline. For age =13 years a resting position (sitting or supine) SBP =120 mmHg and/or a DBP =80 mmHg, at Baseline.
- •9. Has a clinically significant abnormal ECG at Baseline or any of the following cardiac conduction abnormalities:
- •a. Corrected QT interval using Fridericia’s correction method (QTcF) =450 ms
- •b. PR interval on ECG >220 ms
- •c. Evidence of second- or third-degree atrioventricular block
- •d. Evidence of complete left bundle branch block
- •e. Intraventricular conduction delay with QRS interval on ECG (QRS) >110 ms
- •f. QRS or T wave morphology that could, in the Investigator’s opinion, render QT interval
- •assessment unreliable
- •g. Sick sinus syndrome
- •h. More than one premature ventricular contraction on 12-lead ECG
- •i. Non-sinus rhythm
- •j. Resting heart rate <50 beats per minute.
- •One repeat set of triplicate ECGs is allowed at Baseline.
- •10. Weight <15 kg.
研究者
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