A phase II multi-center, randomized, double-blind, 24-week, 3-arm, parallel group, placebo-controlled study to investigate the efficacy and safety of RO5285119 in children and adolescents age 5-17 with autism spectrum disorder (ASD)

Last Updated: Wednesday, April 12, 2017

Principal Investigator:

Description

The aViation study will test a potential new treatment for ‘high-functioning’ autism spectrum disorder (ASD). The investigational study drug blocks a hormone receptor in the brain that is linked to the control of socialization, stress, anxiety and aggression.

Participation lasts for up to 39 weeks. For 24 of those weeks, they will take daily doses of either the investigational study drug or a placebo (a look-alike) that contains no medicine. Both the investigational study drug and the placebo are small tablets that can be swallowed whole or dissolved in liquid.

Participants and their parent or guardian will visit a study clinic around once every 6 weeks (about 7 times in total). This will allow the study team to assess their general health, social communication skills and social interaction skills.

In between these clinic visits, a nurse will need to take some additional blood samples. To do this, they’ll either visit you at your home or you’ll be asked to go back to the clinic.

Visits may include questionnaires, blood/urine samples, cognitive testing or physical exams at no cost to you.

Your time will be compensated.

This study is sponsored by Roche Pharmaceuticals.

Participant Criteria

Children and adolescents, 5-17 years old, with autism spectrum disorder

Compensation

Evaluations, study visits, and study drug are provided at no cost. and $50 per site visit.

Visit Requirements

7 visits to Vanderbilt University

Brochure

Download Brochure

Contact Information

Sarah Marler
615 936 3288
sarah.marler@vanderbilt.edu

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Also...

To be notified when you are a possible match for a research study looking for participants, register with Vanderbilt's ResearchMatch at the link below.

Research Match
ResearchMatch.org is a free and safe national website that matches research volunteers with researchers looking for participants. Registries for Autism and Intellectual Disabilities are now available on ResearchMatch. Everyone is welcome to join, regardless of age, or condition. Visit www.researchmatch.org to learn more and to join today.