A Study of OV101 in Individuals With Fragile X Syndrome

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.