Have You or Your Child Been Diagnosed with Autism? Do You or Your Child Suffer from Significant Irritability?

Why are we doing this research?

The purpose of this research study is to test the safety and effectiveness (usefulness) of riluzole for the treatment of aggression, self-injury and tantrums in adolescents with autism spectrum disorders. 

Who can participate?

Children, teens and adults 12 to 25 years old who:

  • Have a diagnosis of autism, Asperger’s disorder (not associated with Fragile X Syndrome or other known cause) or pervasive developmental disorder not otherwise specified
  • Suffer from symptoms of significant irritability
  • Have a history of treatment with medications for irritability that have not been effective
  • Weigh at least 110 pounds


  • Autism - Fragile X

What will happen in the study?

You or your child will take part in this research study for about 14 weeks and complete 7 study visits.

You or your child will be "randomized" into 1 of 2 study groups. Randomization means that your child will be put into a study group completely by chance, like flipping a coin. You or your child will have an equal chance of being placed either group. Each participant in the study will receive 5 weeks of treatment with the study drug and 5 weeks of treatment with placebo, with a 2 week wash-out period between treatment arms. You or your child will be randomized into a group that receives either study medication or placebo first. Neither you, your child, nor the researcher conducting this study will know what group your child will be in.

During the study, your child will be complete some tests and procedures, including:

  • Review of medical and medication history
  • Physical exam (height, weight, temperature, pulse, and blood pressure)
  • Electrocardiogram  or ECG (a painless test of the heart’s rhythm)
  • Test to diagnosis autism (if needed)
  • Behavioral tests
  • Blood draw
  • Questions about you or your child’s symptoms, behavior and changes you may observe
  • Weekly phone calls with the study staff

 A detailed list of procedures will be provided to anyone interested in knowing more about this study.  

What are the good things that can happen from this research?

You or your child may receive a direct medical benefit from participating in this study. The information gained from this study may benefit other patients with autism spectrum disorders and their families in the future.

Will I get all the facts about the study?

If interested in participating, you, as a participant or as a parent of a participant, will be given a consent form that explains all of the details of the study.  The form covers all of the procedures, risks, benefits, pay, whom to contact with questions or concerns and more.  A member of the study staff will review the consent form with you and will be sure that all of your questions are answered.  

What are the bad things that can happen from this research?

Any discomforts or risks will be discussed with you if you are interested in learning more about the study.

Will you/your child be paid to be in this research study?

Participants will not be compensated for their time for this study.


Contact Us.autism@cchmc.org 
Cincinnati Children’s Hospital Medical Center 
Division of Child Psychiatry
3333 Burnet Ave., MLC 4002
Cincinnati, OH  45229-3039

Study Doctor

Contact Us.Logan Wink, MD
Division of Pediatric Psychiatry
Cincinnati Children’s Hospital Medical Center