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

NCT03504917 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 322

Last updated 2021-10-27

Study results available
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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).

Conditions

Interventions

DRUG

Balovaptan

Participants will receive 10 mg of oral administration balovaptan once a day (QD).

DRUG

Placebo

Participants will receive matching placebo.

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-08
Primary Completion
2020-03-04
Completion
2020-07-01
FDA Drug
Yes

Countries

  • United States
  • Canada
  • France
  • Italy
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03504917 on ClinicalTrials.gov