EUCTR2019-003524-20-IT进行中（未招募）1 期
A phase II multicenter, randomized, double-blind, 12-week treatment, 3-arm, parallel-group, placebo-controlled study to investigate the efficacy, safety and tolerability of RO7017773 in participants aged 15 to 45 with Autism Spectrum Disorder (ASD) - na
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 105
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
- •-Age 15 to 45 years
- •-Males and female participants with Autism Spectrum Disorder according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)
- •-Wechsler Abbreviated Scale of Intelligence (WASI-II) >= 50 at screening or within the last 12 months prior to screening
- •-ASD or Autism diagnosis confirmed by Autism Diagnostic Observation Schedule (ADOS-2)
- •-Body mass index within the range of 18.5 to 40 kg/m2
- •-Female Participants: is eligible if she is not pregnant, not breastfeeding, and women of childbearing potential (WOCBP), who agree to remain abstinent or use contraceptive methods that result in a failure rate of < 1% per year during the treatment period and for at least 28 days after the last dose of study drug
- •-Language, hearing, and vision compatible with the study measurements as judged by the Investigator.Non-verbal individuals will be excluded from study participation
- •-Allowed existing treatment regimens should be stable for 8 weeks prior to screening except: 6 weeks for non-pharmacological interventions,12 weeks in the case of antipsychotic therapies and 6 months for antiepileptic treatments. Investigator expects stability of these treatments and behavioral interventions for the duration of the study
- •-In the Investigator’s opinion, able to participate and deemed appropriate for participation in the study, capable of following the study SoA and able to comply with the study restrictions
- •-In the Investigator’s opinion, participation in the study or discontinuation of prohibited medication will not pose undue risks
- •Are the trial subjects under 18? yes
- •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 73
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Neurologic/psychiatric conditions
- •-Presence of chromosome 15q11.2 q13.1 duplication syndrome (Dup15q syndrome) genetically defined ASD per genetic results available prior to screening or known syndromic” forms of ASD, such as diagnosis of fragile X syndrome, chromosome 15q11.2-q13.1 duplication syndrome (Dup15q syndrome), Prader Willi syndrome, Rett’s syndrome, or tuberous sclerosis
- •-Medical history of alcohol and/or substance abuse/dependence in the last 12 months or positive test for drugs of abuse at screening
- •-Initiation of a major change in psychosocial intervention within 4 weeks prior to screening. Minor changes in ongoing treatment are not considered major changes
- •-Unstable or uncontrolled clinically significant psychiatric and/or neurological disorder that may interfere with the safety or efficacy endpoints
- •-Risk of suicidal behavior in the opinion of a certified clinician or as evidenced by a yes to questions 4 and/or 5 of Columbia-Suicide-Severity Rating Scale (C-SSRS) taken at screening and baseline with respect to the last 12 months or period since the screening visit, respectively or any suicide attempt in the past 5 years
- •-Unstable epilepsy/seizure disorder within the past 6 months
- •Other conditions
- •-Medical history of malignancy if not considered cured or if occurred within the last 3 years with the exception of fully excised non-melanoma skin cancers or in-situ carcinoma of the cervix that has been successfully treated
- •-Concomitant disease, condition or treatment which would either interfere with the conduct of the study or pose an unacceptable risk to the participant in the opinion of the Investigator
- •-Known active or uncontrolled bacterial, viral, or other infection or any major episode of infection or hospitalization within 6 weeks prior to the start of drug administration
- •Prior/Concomitant Therapy
- •-Use of prohibited medications or herbal remedies within 6 weeks or 5 half-lives (t1/2) prior to randomization
- •Prior/Concurrent Clinical Study Experience
- •-Donation or loss of blood over 500 mL in adults and 250 mL in adolescents within 3 months prior to randomization
- •-Participation in an investigational drug study within 1 month or 5 times the t1/2 of the investigational molecule prior to randomization or participation in a study testing an investigational medical device within 1 month prior to randomization or if the device is still active
- •-Sensitivity to any of the study treatments or components thereof, or drug or other allergy that, in the opinion of the Investigator, contraindicates the participation in the study
- •Diagnostic Assessments
- •-Confirmed clinically significant abnormality in hematological, chemistry or coagulation laboratory parameters
- •-Positive test result at screening for hepatitis B surface antigen, hepatitis C virus (HCV, untreated), or human immunodeficiency virus (HIV)-1 and -2. HCV participants who have been successfully treated and who test negative for HCV RNA, may be considered eligible for entry into the study
- •Other Exclusions
- •-Uncorrected hypokalemia or hypomagnesaemia
研究者
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