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Summary

for people ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

Description

Summary

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).

Official Title

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

Keywords

Autism Spectrum Disorder Disease Autistic Disorder Child Development Disorders, Pervasive

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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 30 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 CAN'T join 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
  • Alcohol or substance abuse or dependence disorder 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
  • 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

Locations

  • University of California at San Francisco not yet accepting patients
    San Francisco, California, 94115, United States
  • University of California , Los Angeles (UCLA); Child, Adolescent Psychiatry not yet accepting patients
    Los Angeles, California, 90095, United States

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
Hoffmann-La Roche
ID
NCT03504917
Phase
Phase 3
Study Type
Interventional
Last Updated
May 7, 2018
I’m interested in this study!