Clinical Trials

5 to 17 Year Olds with Fragile X Syndrome Needed for a Research Study

What is the purpose of this study?

The purpose of this research study is to learn more about the safety, tolerability and effectiveness of an investigational drug treatment called acamprosate and see if it reduces the symptoms (inattention/hyperactivity, social impairment) associated with Fragile X Syndrome (FXS).

Investigational means that this drug has not currently been approved by the United States Food and Drug Administration (FDA) for the treatment of FXS.

Who can participate?

Children and teens 5 to 17 years old who have been diagnosed with FXS may be eligible for participation.

What is involved?

You and your child will come to Cincinnati Children’s for all study visits. You must attend and bring your child to all study visits to be in this study. The first phase of the study will last between 10 to 20 weeks. Your child may have an opportunity to participate in a second phase of the study, which lasts 16 weeks.

Your child will be randomly (by chance) assigned to treatment with either acamprosate or placebo (an inactive form of medication). Neither you, your child, nor the researchers conducting the study will know what group your child is in.

While in this study, you, as the parent or guardian, will be asked to complete some tests and procedures, including:

  • Review of your child’s medical and psychiatric history
  • Interviews/questionnaires about your child’s symptoms, behaviors and everyday living skills (both over the phone and in the clinic)
  • Blood sample

While in this study, your child will be asked to complete some tests and procedures, including:

  • Physical exam and vital signs (height, weight, temperature, blood pressure and pulse)
  • Blood sample
  • Measurement of the circumference of the head
  • Completion of an IQ test
  • A structured interaction/play session with your child will be completed with a member of the research team.
  • Eye-gaze assessment
  • Expressive language sampling

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 FXS in the future.

Will I get all the facts about the study?

If interested in participating, 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 very 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 will be reimbursed $20 per visit for their time and travel.

Who should I contact for more information?

fragilex@cchmc.org 

513-636-0523

Cincinnati Children’s Hospital Medical Center

3333 Burnet Avenue

Cincinnati, OH  45229-3039


Principal Investigator

Craig Erickson, MD

Division of Child Psychiatry

Cincinnati Children’s Hospital Medical Center