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 208 weeks (four years). Over this time, participants will have three safety phone calls and 15 assessment visits. Of the 15 assessments, nine 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.

Travel to and from sites for a study participant and his caregiver may be covered by Shionogi and may include transportation and lodging arrangements, as well as reimbursement for expenses, such as meals (limitations may apply).
Zatolmilast is an investigational drug. Safety and efficacy have not been established. There is no guarantee that zatolmilast will be approved by any health authority.

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 four years (208 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, 104, 130, 156, 182 and 208

Safety and efficacy.

Weeks 65 and 91

Safety (phone call).

Week 210

Follow-up phone call.

*Safety visits may be completed remotely using a designated visiting nurse service, followed by a call from a clinic.