Autism Spectrum Disorder (ASD) Clinical Trial
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)
Verified date | June 2024 |
Source | Hoffmann-La Roche |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Hoffmann-La Roche |
United States, Canada, Italy, Spain,
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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