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)
a study on Autism
Summary
- Eligibility
- for people ages 15-45 (full criteria)
- Location
- at San Francisco, California and other locations
- Dates
- study startedestimated completion
Description
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 and who have a score of >/=50 on the Wechsler Abreviated Scale of Intelligence (WASI-II).
Official Title
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 15-45 Years With Autism Spectrum Disorder (ASD)
Keywords
Autism Spectrum Disorder (ASD) Autistic Disorder Autism Spectrum Disorder Child Development Disorders, Pervasive
Eligibility
You can join if…
Open to people ages 15-45
- 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
You CAN'T join if...
Neurologic/Psychiatric Conditions:
- Presence of genetically defined ASD per genetic results available prior to screening or known "syndromic" forms of ASD (e.g. 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 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
Locations
- University of California at San Francisco
San Francisco California 94115 United States - Southwest Autism Research & Resource Center
Phoenix Arizona 85006 United States
Details
- Status
- not yet accepting patients
- Start Date
- Completion Date
- (estimated)
- Sponsor
- Hoffmann-La Roche
- ID
- NCT04299464
- Phase
- Phase 2
- Study Type
- Interventional
- Last Updated