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



Status:Recruiting
Conditions:Neurology, Psychiatric, Psychiatric, Autism
Therapuetic Areas:Neurology, Psychiatry / Psychology
Healthy:No
Age Range:18 - Any
Updated:3/27/2019
Start Date:August 8, 2018
End Date:March 31, 2023
Contact:Reference Study ID Number: WN39434 www.roche.com/about_roche/roche_worldwide.htm
Email:global-roche-genentech-trials@gene.com
Phone:888-662-6728 (U.S. Only)

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A Phase III, Randomized, Double-Blind, Placebo-Controlled, Efficacy, and Safety Study of Balovaptan in Adults With Autism Spectrum Disorder With a 2-Year Open-Label Extension

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).


Inclusion Criteria:

- 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

Exclusion Criteria:

- 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
We found this trial at
36
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Pittsburgh, Pennsylvania 15213
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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Austin, Texas 78759
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1800 Orleans St.
Baltimore, Maryland 21287
410-955-5000
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Bellevue, Washington 98007
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1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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Cleveland, Ohio 44106
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Colorado Springs, Colorado 80910
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281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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Dothan, Alabama 36303
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2608 Erwin Road
Durham, North Carolina 27705
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Gainesville, Florida 32607
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Houston, Texas 17115
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1353 Ellis Street
Kelowna, British Columbia V1Y 1Z9
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Lake Charles, Louisiana 70601
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2450 Riverside Ave
Minneapolis, Minnesota 55454
(612) 273-3000
University of Minnesota Medical Center, Fairview Improving patients' lives drives the innovation that makes University...
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New Haven, Connecticut 06510
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New York, New York 10019
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Oakland Park, Florida 33334
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Oklahoma City, Oklahoma 73116
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Orem, Utah 84058
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Orlando, Florida 32803
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Palmetto Bay, Florida
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609 West Dyke Road
Rogers, Arkansas 72758
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Saint Louis, Missouri 63132
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San Diego, California 92108
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San Francisco, California 94143
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4800 Sand Point Way NE
Seattle, Washington 98105
(206) 987-2000
Seattle Children's Hospital Seattle Children’s Hospital specializes in meeting the unique physical, emotional and developmental...
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Staten Island, New York 10312
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