a 12-week placebo-controlled study to investigate the efficacy, safety, and tolerability of ro7017773 in participants aged 15-45 years with autism spectrum disorder (asd)

Conditions: Autism Spectrum Disorder (ASD)

Summary: this study will investigate the efficacy, safety, tolerability, and pharmacokinetics of ro7017773 in participants aged 15-45 years who have been diagnosed with asd with a score of \>/=50 on the wechsler abreviated scale of intelligence (wasi-ii).


Eligibility criteria:
inclusion criteria * male 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 * allowed existing treatment regimens should be stable for 8 weeks prior to screening. 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 exclusion criteria neurologic/psychiatric conditions: * non-verbal individuals * presence of chromosome 15q11.2 q13.1 duplication syndrome (dup15q syndrome), known "syndromic" forms of asd (confirmed per genetic results available at screening): fragile x syndrome, prader willi syndrome, rett's syndrome, tuberous sclerosis, and angelman syndrome, as well as genetic alterations strongly associated with asd per genetic results available at screening affecting the following genes: chd8, andp, shank3 * 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 6 weeks prior to screening. minor changes in ongoing treatment are not considered major changes * 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 any suicide attempt in the past 5 years * unstable epilepsy/seizure disorder within the past 6 months or changes in anticonvulsive therapy within the last 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 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 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 exculsions: * uncorrected hypokalemia or hypomagnesaemia