Autism – Use of Investigational Medication for Autism Symptoms

Description

Dr. Robert Hendren, director of the Autism and Neurodevelopment Program at UCSF, is beginning a new clinical research study using an experimental medication for the treatment of autism -RO5285119.  RO5285119 is an investigational drug currently being developed by F. Hoffmann-La Roche Ltd. as a potential treatment for autism. It is hoped that this medication may benefit the core symptoms in some individuals with autism: social behavior and communication.

Autism Spectrum Disorders are a group of brain development disorders including autism. Currently, there are no medications available to treat symptoms of autism such as abnormal social behavior and communication. RO5285119 works by blocking a brain receptor of a hormone (the vasopressin receptor) that is associated with control of stress, anxiety, affection and aggression. RO5285119 could therefore be an effective treatment for the main symptoms associated with autism.

This study will compare RO5285119 to placebo (an inactive substance, like a sugar pill), so there is a 50% chance that you would receive the placebo. The study will last twelve weeks, and will involve up to 7 visits in 18 weeks to Dr. Hendren’s office for health checks.  Other visits may be done at home with a study nurse.  During the course of the study you will receive a thorough diagnostic evaluation, physical exams, monitoring of blood pressure, pulse, height and weight and frequent examination of symptoms of autism. There is no cost to participating in the study and we can provide a small payment at each visit to help cover the expenses of time, travel and parking.

Study Design

12-week double blind, parallel group, placebo-controlled

Principal Investigators

Robert Hendren, DO

Participant Requirements

  • Be an adult male aged 18 to 45 years with an autism spectrum disorder.
  • Be available to come to our clinic in San Francisco, CA multiple times. (This is a nationwide study. You are welcome to use another site, if it is more convenient.)
  • Have an information provider (spouse, family member, friend) who is willing to accompany the participant to the clinic to share their observations about any changes in the participant’s social behavior and communication.

Payment

$40 for each clinic visit

 

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