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Status:

COMPLETED

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)

Lead Sponsor:

Hoffmann-La Roche

Conditions:

Autism Spectrum Disorder (ASD)

Eligibility:

All Genders

15-45 years

Phase:

PHASE2

Brief 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 Wechsl...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    March 31 2021

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    May 15 2024

    Estimated Enrollment :

    104 Patients enrolled

    Trial Details

    Trial ID

    NCT04299464

    Start Date

    March 31 2021

    End Date

    May 15 2024

    Last Update

    January 28 2025

    Active Locations (21)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 6 (21 locations)

    1

    Southwest Autism Research and Resource Center

    Phoenix, Arizona, United States, 85006

    2

    Yale University / Yale-New Haven Hospital

    New Haven, Connecticut, United States, 06519-1124

    3

    APG- Advanced Psychiatric Group

    Orlando, Florida, United States, 32803

    4

    Rush University Medical Center

    Chicago, Illinois, United States, 60612