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.