A Study of the Experimental Medicine OV101 For Fragile X Syndrome

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"Volunteer for research at UC Davis and contribute to discoveries that may improve health care for you, your family, and your community!"
Age: 13 to 22 years old
Gender:
Male
Healthy Volunteers: No
Keywords: fragile x syndrome
Type: Drug study, Phase 2
Target:
6 Participants
Investigator:
Description
We invite you to take part in a research study because your child has a rare genetic disorder called Fragile X syndrome (FXS). You are being asked to give permission for your child to take part in the study. If you are a parent/legally authorized representative (LAR), you are being asked to take part in this study as detailed in this consent form. Before you decide if you want to take part, it is important for you to understand why the research is being done and what it will involve. Please read the following information carefully and discuss it with friends, family and physician if you wish. The study doctor or study staff will also explain the study to you.
This study requires

The study team will make sure you qualify to take part in the study. Qualified participants will receive detailed information about the study. This may include a list of study-related tests and procedures.

Who can participate

Inclusion criteria:

  • Is male and 13 to 22 years old (inclusive) at the time of informed consent.
  • Has a diagnosis of FXS with a confirmed FMR1 full mutation (≥200 CGG repeats).

Exclusion criteria:

  • Concomitant disease or condition that are clinically significant and would limit study participation
  • Clinically significant lab abnormalities or vital signs at the time of screening
  • History of uncontrollable seizure disorder or seizure episodes within 6 months of screening or change in the anticonvulsant pharmacotherapy in the past 3 months.
  • Unable or does not have a caregiver able to comply with study requirements.
  • Enrolled in any clinical trial within the 30 days before screening.
Benefits and risks of participating
BENEFITS:

We cannot promise any benefits to you as a result of taking part in this research study.


RISKS:

The study doctor will discuss the risks associated with taking part in this research study.
Compensation
The Sponsor will provide:
• Reasonable hotel accommodation during clinical visits where applicable.
• Travel costs for you and your child if air, train, ground transportation, or bus accommodations are required.
• You will be paid $60 per office visit for your time and inconvenience.
• In addition, you will receive reimbursement for pharmacokinetic visits up to $120 total ($30 per visit).
Resources
Schedule
Study duration and period
We expect that you will be in this research study for approximately 21 weeks.
Recruitment period
From Dec. 20, 2018
Location
UC Davis MIND Institute
2825 50th Street
Sacramento, CA 95817
Contact
Laura Pulido-Ramirez
Research Topic
Conditions:
  • Fragile X Syndrome (FXS)