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

What is the purpose of this study?

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

What is involved?

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 benefits?

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 risks and discomforts of the study?

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

Do participants receive pay, compensation or reimbursement?

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

Who should I contact for more information?

autism@cchmc.org

513-636-0523

Cincinnati Children’s Hospital Medical Center

Division of Child Psychiatry

3333 Burnet Ave., MLC 4002

Cincinnati, OH  45229-3039

Principal Investigator

Logan Wink, MD

Division of Pediatric Psychiatry

Cincinnati Children’s Hospital Medical Center