A Study of Balovaptan in Adults With Autism Spectrum Disorder With a 2-Year Open-Label Extension

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Autism Spectrum Disorder

In brief

This study will evaluate the efficacy, safety, and pharmacokinetics of 10 mg of oral administration balovaptan once a day (QD) compared with matching placebo in adults (18 years and older) with autism spectrum disorder (ASD).

Key facts

Study ID

NCT03504917

Run by

Hoffmann-La Roche

People needed

322

Starts

2018-08-08

Expected to finish

2020-07-01

Last updated by the study team

2021-10-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject meets the DSM-5 criteria for ASD for an autism diagnosis and is confirmed using ADOS-2 criteria
• SRS-2, proxy version, total t-score >=66 at screening
• A full scale IQ score >=70 on the WASI®-II
• Subject has an appropriate study partner, in the opinion of the investigator
• For women of childbearing potential: agreement to remain abstinent or use a contraceptive method with a failure rate of <1% per year during the treatment period and for at least 28 days after the last dose of study drug
• Treatment with permitted medications (at a stable dose for 12 weeks before screening) and behavioral therapy regimens (regimens stable for 6 weeks before screening), with the intent that such treatments remain stable throughout the study and with no expected changes before the Week 24 visit

You may not qualify if…

• Pregnancy or breastfeeding, or intention to become pregnant during the study
• Previous initiation of new or major change in psychosocial intervention within 6 weeks prior to screening
• Unstable or uncontrolled clinically significant affective or psychotic disorders and/or neurologic disorder that may interfere with the assessment of safety or efficacy endpoints
• Substance use disorders during the last 12 months
• Significant risk for suicidal behavior, in the opinion of the investigator
• Epilepsy or seizure disorder considered not well controlled within the past 6 months or changes in anticonvulsive therapy within the last 6 months
• Clinical diagnosis of peripheral neuropathy
• Within the last 2 years, unstable or clinically significant cardiovascular disease
• Uncontrolled hypertension
• Unexplained syncopal episode within the last 12 months
• Confirmed elevation above upper limit of normal of CK-MB, high sensitivity cardiac troponin T, cardiac troponin I, and/or N-terminal pro B-type natriuretic peptide
• Positive serology results for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, or human immunodeficiency virus (HIV) 1 or 2
• History of coagulopathies, bleeding disorders, blood dyscrasias, hematological malignancies, myelosuppression (including iatrogenic), or current major bleeding event
• Concomitant disease or condition that could interfere with, or treatment of which might interfere with, the conduct of the study, or what would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study
• Confirmed clinically significant abnormality in parameters of hematology
• Confirmed clinically significant abnormality in parameters of clinical chemistry, coagulation, or urinalysis
• Medical history of malignancy, if not considered cured

Where it is running

• Southwest Autism Research & Resource Center — Phoenix, Arizona, United States
• Woodland Research Northwest, LLC — Rogers, Arkansas, United States
• University of California , Los Angeles (UCLA); Child, Adolescent Psychiatry — Los Angeles, California, United States
• PCSD Feighner Research — San Diego, California, United States
• University of California at San Francisco — San Francisco, California, United States
• MCB Clinical Research Centers — Colorado Springs, Colorado, United States
• Yale University / Yale-New Haven Hospital — New Haven, Connecticut, United States
• Sarkis Clinical Trials — Gainesville, Florida, United States
• APG- Advanced Psychiatric Group — Orlando, Florida, United States
• IMIC Inc. — Palmetto Bay, Florida, United States
• Rush University Medical Center — Chicago, Illinois, United States
• Uni of Chicago; Centre For Advanced Medicine — Chicago, Illinois, United States
• Lake Charles Clinical Trials, LLC — Lake Charles, Louisiana, United States
• The Johns Hopkins Hospital — Baltimore, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• University of Minnesota Medical Center-Fairview — Minneapolis, Minnesota, United States
• Millennium Psychiatric Associates, LLC — St Louis, Missouri, United States
• Hapworth Research Inc. — New York, New York, United States
• Center for Autism and the Developing Brain — New York, New York, United States
• Nathan S. Kline Institute for Psychiatric Research — Orangeburg, New York, United States
• Richmond Behavioral Associates — Staten Island, New York, United States
• University Hospitals — Cleveland, Ohio, United States
• Ohio State University — Columbus, Ohio, United States
• Cutting Edge Research Group — Oklahoma City, Oklahoma, United States
• Harmonex Neuroscience Research — Dothan, Alabama, United States

Full record on ClinicalTrials.gov

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