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
- 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)
to diagnosis autism (if needed)
- 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.