5 to 17 Year Olds with Autism Needed for an Investigational Medication Research Study
What is the purpose of this study?
The purpose of this research study is to understand the safety and
effectiveness of an investigational medication, called acamprosate, and see if
it reduces the symptoms associated with
autism, such as social and communication problems.
Investigational means that this drug has not currently been approved
by the United States Food and Drug Administration (FDA) to treat autism.
Who can participate?
and teens 5 to 17 years old who:
- Have been diagnosed with autism
- Have been seizure free for at least 6 months
What is involved?
After qualification and screening, your child will be in the research study for about 10 weeks and have a total of 6 study visits (1 baseline visit and 5 medication/clinic visits). In addition to the clinic visits, you will have up to 3 phone call visits from the investigator. During the phone call visits, the investigator will ask you how your child is responding to the study drug and the may adjust the dose.
Your child will receive either the study drug a placebo (an inactive substance or “sugar pill”) for 10 weeks. You, your child and the researchers conducting this study will not know what group your child is in. But, if there is an emergency, researchers are able to get this information.
A detailed list of procedures will be provided to anyone interested in knowing more about this study.
What are the benefits?
Your child may not receive a direct medical benefit from participating in this study. However, the information learned from this study may benefit other patients with autism in the future.
Will I get all the facts about the study?
If you are interested in having your child participate, you 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?
There are minimal risks associated with participation in this 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 may receive up to $280 for completing all of the study visits (or $20 per visit).