EXPERIENCE-302: Open-Label Extension Study in Fragile X Syndrome

About EXPERIENCE-302
Participants who have completed EXPERIENCE-204 or EXPERIENCE-301 may continue to participate in EXPERIENCE-302 (also known as BPN14770-CNS-302 or NCT05367960), an open-label extension study that will last up to 104 weeks (two years). Over this time, participants will have up to three safety phone calls and 11 assessment visits. Of the 11 assessments, five are in-person safety and efficacy visits, and six are safety visits (either in-person or at home by a visiting nurse). A follow-up phone call will take place two weeks after the study concludes.
Eligibility Requirements
Participants must have a genetic diagnosis of Fragile X syndrome (FXS) and meet the following criteria:
Must enroll within one week of completing Week 13 of EXPERIENCE-204 or EXPERIENCE-301.
Up to two years (104 weeks) in which all participants will receive zatolmilast (investigational study drug).
EXPERIENCE-302 Schedule
Day 1
In-person safety and efficacy (approximately four hours).
Weeks 4, 8, 10, 17, 21 and 39
Safety.*
Weeks 13, 26, 52, 78 and 104
Safety and efficacy.
Weeks 65 and 91
Safety (phone call).
Week 106
Follow-up phone call.