CTIS2023-503678-18-00招募中1 期
An Exploratory, Multicenter, Randomized, double-blind, placebo-controlled study evaluating the effect and safety of pitolisant in children and adolescents with Autism Spectrum Disorders. - P21-01
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 66
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 0 至 17（—）
- 性别
- Male
入选标准
- •Participants (if possessing adequate understanding, in the investigator's opinion) and their parent(s)/legal guardian(s) are willing and able to give informed assent and consent for participation in the study., Participants should benefit from appropriate health insurance system (for French participant only)., Male children and adolescents aged from 6 to 17 inclusive for the duration of study participation., Participants have a diagnosis of autism spectrum disorders as per the DSM-5 criteria confirmed by ADOS-2 or ADI-R historical diagnosis within the last 3 years prior to screening or by ADI-R at screening., Participants have an Intelligence Quotient (IQ) = 70 using Wechsler Intelligence Scale (WAIS-IV or WISC-V) confirmed by historical data within the last 3 years or at screening. If total IQ score is unconclusive due to heterogenicity of sub-scores, participant should have at minimum both sub-scores for verbal comprehension and perceptual reasoning = 70., Social Responsiveness Scale Second Edition (SRS-2) total T-score = 66 at screening and baseline., All ongoing medications or interventions (except those listed as prohibited in previous and concomitant medications/therapy” section) for ASD related symptoms must have been stable for at least 4 weeks prior to screening, and the participant/caregiver must be willing to maintain a stable regimen throughout the study., Participants’ language, hearing and vision must be compatible with the study assessments as judged by the investigator., Participants must have the ability to swallow the investigational medicinal product (IMP)., Participant has a care provider who can reliably bring participant to clinic visits, provide trustworthy ratings, support participant with study compliance requirements, and interacts with the participant on a regular basis (e.g., spends at minimum 3 hours/ day and 4 x /week).
排除标准
- •Participants with previous genetic diagnosis of ASD-known syndromic ASD (e.g., Fragile X syndrome, Angelman syndrome, Prader-Willi, Rett's syndrome, tuberous sclerosis, Dup15q syndrome)., Other active clinically significant illness, infection, acid-related gastric disorders, or neoplastic pathology within the last 3 years which could interfere with the study conduct or counter-indicate the study treatments or place the participant at risk during the study or compromise his study participation., Known or suspected history of alcohol or illicit drug (e.g., cannabis, amphetamines or opioids when not prescribed and used under medical supervision) or any history of cocaine abuse/dependence prior to screening according to investigator judgement., Any positive test of abuse drugs at screening., Prior (within the last 4 weeks prior to screening) or current therapy with strong CYP2D6 inhibitor drugs, strong CYP3A4 inducer drugs, antipsychotics medications, first-generation antihistamines (H1-antagonists) crossing the blood-brain barrier and tricyclic antidepressants as detailed in the previous and concomitant medications/therapy” section., Known hypersensitivity to the investigational medicinal product including active substance and excipients., Any participant presenting congenital galactosemia, glucose-galactose malabsorption or lactase deficiency due to the presence of lactose in the investigational medical product (IMP)., Participants taking part in another interventional study and/or the use of any investigational therapy within the 30 days prior to screening., Participant with a family relationship to a person involved in the study at the investigator’s site, at the Clinical Research Organisation (CRO) or at the Sponsor., Participants having a diagnosis other than ASD that dominates the clinical presentation (e.g., Attention-Deficit/Hyperactivity Disorder (ADHD), anxiety disorder, depressive disorder) per investigator judgement., Participant with a history of suicidal behavior or suicidal ideation in the past 12 months, or a positive answer to questions 4 or 5 on the Columbia-Suicide-Severity Rating Scale (C-SSRS) at screening and/or baseline, and/or is a significant risk for suicidal behavior per investigator judgement., History or current diagnosis of major depressive episode or severe psychiatric disorders, e.g., schizophrenia, bipolar disorder, organic brain syndrome or psychosis, preventing the participant from completing the study assessments per investigator judgement., History or current diagnosis of epilepsy or any seizure occurring after the age of 5., Participants with a clinically significant deviation from normal on 12-lead ECG that results in an active medical problem, per investigator judgement or, with a QTcF > 450ms at screening., Participants with severe hepatic impairment (Child Pugh C) or with any other hepatic significant abnormality in the physical examination or ALAT or ASAT = 2x Upper Limit of Normal (ULN) for age at laboratory results., Participants with clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further clinical investigation per investigator judgement., Any abnormalities identified following a physical examination of the participant that, in the opinion of the investigator, would jeopardize the safety of the participant if he took part in the study.
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