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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04299464
Other study ID # BP41316
Secondary ID 2019-003524-20
Status Completed
Phase Phase 2
First received
Last updated
Start date March 31, 2021
Est. completion date May 17, 2024

Study information

Verified date June 2024
Source Hoffmann-La Roche
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Completed
Enrollment 103
Est. completion date May 17, 2024
Est. primary completion date May 17, 2024
Accepts healthy volunteers No
Gender All
Age group 15 Years to 45 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Placebo
Participants will receive oral placebo for approximately 12 weeks.
RO7017773
Participants will receive oral RO7017773 for approximately 12 weeks.

Locations

Country Name City State
Canada Holland Bloorview Kids Rehabilitation Hospital; Autism Research Centre East York Ontario
Canada University of Alberta Edmonton Alberta
Canada Okanagan Clinical Trials Kelowna British Columbia
Canada London Health Sciences Centre; Victoria Hospital London Ontario
Canada Janeway Childrens Health; and Rehabilitation Centre St. John's Newfoundland and Labrador
Italy Istituto Scientifico Medea; U.O Psicopatologia età evolutiva Bosisio Parini (LC) Lombardia
Italy IRCCS Fondazione Stella Maris; U.O. Complessa NPI 3 - Psichiatria dello sviluppo Calambrone (PI) Toscana
Italy P.O. Gaspare Rodolico; UOC Clinica Psichiatrica Catania Sicilia
Italy Ist. G. Gaslini; UOC Neuropsichiatria Infantile Genova Liguria
Italy Azienda Ospedaliera Universitaria Federico II; U.O.S.D. Neuropsichiatria Infantile Napoli Campania
Italy ASST di Pavia; Dip. di Scienze del Sistema Nervoso e del Comportamento Pavia Lombardia
Italy AOU Policlinico Tor Vergata, Università Roma Tor Vergata Roma Lazio
Spain Hospital Universitari Vall d'Hebron; Sevicio de Psiquiatría Barcelona
Spain IGAIN (Instituto Global de Atención Integral al Neurodesarrollo) Barcelona
Spain Hospital General Universitario Gregorio Marañon; Instituto Provincial de Psiquiatría Madrid
Spain Hospital Universitario Infanta Leonor; Servicio de Psiquiatría Madrid
United States Montefiore Medical Center Bronx New York
United States Rush University Medical Center Chicago Illinois
United States University Hospitals Cleveland Ohio
United States Ohio State University Columbus Ohio
United States University of Minnesota Minneapolis Minnesota
United States Vanderbilt Medical Center Nashville Tennessee
United States Yale University / Yale-New Haven Hospital New Haven Connecticut
United States Nathan Kline Institute Orangeburg New York
United States APG- Advanced Psychiatric Group Orlando Florida
United States Southwest Autism Research and Resource Center Phoenix Arizona
United States UPMC Western Psychiatric Institute and Clinic Pittsburgh Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Canada,  Italy,  Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from Baseline to Week 12 in the Adaptive Behavior Composite score of the Vineland Adaptive Behavior Scales, Third Edition (Vineland-3) Week 12
Secondary Percentage of Participants with Adverse Events (AEs) Up to Week 18
Secondary Percentage of Participants with Serious Adverse Events (SAEs) Up to Week 18
Secondary Percentage of Participants Discontinuing Treatment due to AEs From Baseline up to Week 12
Secondary Change from Baseline Over Time in Suicide Risk Using the Columbia-Suicide-Severity Rating Scale (C-SSRS) Days 14, 42, 84, 98, 126
Secondary Change from Baseline to Week 12 in Behavior/Symptoms as Measured by all Domains of the Repetitive Behavior Scale-Revised (RBS-R) Week 12
Secondary Change from Baseline to Week 12 on the Vineland-3 Socialization Domain Week 12
Secondary Change from baseline to Week 12 on the Vineland-3 Communication domains Week 12
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