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)

Use our guide to learn which trials are right for you!

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
sites
1353 Ellis Street
Kelowna, British Columbia V1Y 1Z9
?
mi
from
Kelowna,
Click here to add this to my saved trials
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
?
mi
from
Boston, MA
Click here to add this to my saved trials
Austin, Texas 78759
?
mi
from
Austin, TX
Click here to add this to my saved trials
1800 Orleans St.
Baltimore, Maryland 21287
410-955-5000
Johns Hopkins Hospital Patients are the focus of everything we do at The Johns Hopkins...
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
Bellevue, Washington 98007
?
mi
from
Bellevue, WA
Click here to add this to my saved trials
?
mi
from
Bronx, NY
Click here to add this to my saved trials
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...
?
mi
from
Chicago, IL
Click here to add this to my saved trials
?
mi
from
Chicago, IL
Click here to add this to my saved trials
Cleveland, Ohio 44106
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
Colorado Springs, Colorado 80910
?
mi
from
Colorado Springs, CO
Click here to add this to my saved trials
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...
?
mi
from
Columbus, OH
Click here to add this to my saved trials
Dothan, Alabama 36303
?
mi
from
Dothan, AL
Click here to add this to my saved trials
2608 Erwin Road
Durham, North Carolina 27705
?
mi
from
Durham, NC
Click here to add this to my saved trials
Gainesville, Florida 32607
?
mi
from
Gainesville, FL
Click here to add this to my saved trials
Houston, Texas 17115
?
mi
from
Houston, TX
Click here to add this to my saved trials
Lake Charles, Louisiana 70601
?
mi
from
Lake Charles, LA
Click here to add this to my saved trials
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
2450 Riverside Ave
Minneapolis, Minnesota 55454
(612) 273-3000
University of Minnesota Medical Center, Fairview Improving patients' lives drives the innovation that makes University...
?
mi
from
Minneapolis, MN
Click here to add this to my saved trials
?
mi
from
Nashville, TN
Click here to add this to my saved trials
New Haven, Connecticut 06510
?
mi
from
New Haven, CT
Click here to add this to my saved trials
?
mi
from
New York, NY
Click here to add this to my saved trials
New York, New York 10019
?
mi
from
New York, NY
Click here to add this to my saved trials
Oakland Park, Florida 33334
?
mi
from
Oakland Park, FL
Click here to add this to my saved trials
Oklahoma City, Oklahoma 73116
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
?
mi
from
Orangeburg, NY
Click here to add this to my saved trials
Orem, Utah 84058
?
mi
from
Orem, UT
Click here to add this to my saved trials
Orlando, Florida 32803
?
mi
from
Orlando, FL
Click here to add this to my saved trials
Palmetto Bay, Florida
?
mi
from
Palmetto Bay, FL
Click here to add this to my saved trials
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
Pittsburgh, Pennsylvania 15213
?
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
609 West Dyke Road
Rogers, Arkansas 72758
?
mi
from
Rogers, AR
Click here to add this to my saved trials
Saint Louis, Missouri 63132
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
San Diego, California 92108
?
mi
from
San Diego, CA
Click here to add this to my saved trials
San Francisco, California 94143
?
mi
from
San Francisco, CA
Click here to add this to my saved trials
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...
?
mi
from
Seattle, WA
Click here to add this to my saved trials
Staten Island, New York 10312
?
mi
from
Staten Island, NY
Click here to add this to my saved trials