NCT05367960

An Open-Label Extension Study of BPN14770 in Subjects With Fragile X Syndrome

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 314 (actual)
• Sponsor: Tetra Discovery Partners · Industry
• Sex: Male
• Age: 9 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

This is a 4-year, open-label extension (OLE) study for subjects completing one of two double-blind clinical trials with BPN14770, Study BPN14770-CNS-301 (in adult males) and Study BPN14770-CNS-204 (in adolescent males).

Detailed description

This is a 4-year open-label extension (OLE) study for subjects completing one of two double-blind clinical trials with BPN14770, Study BPN14770-CNS-301 (in adult males) and Study BPN14770-CNS-204 (in adolescent males). The primary objective of this OLE is to assess the long-term safety and tolerability of BPN14770 in these subjects with fragile X syndrome (FXS) who were treated in one of those parent clinical trials.

Conditions

• Fragile X Syndrome

Interventions

Type	Name	Description
DRUG	Zatolmilast/ BPN14770	25mg zatolmilast/BPN14770 (Adults) or 15 mg zatolmilast/BPN14770 (Adolescents \<43 kg)

Timeline

• Start date: 2022-11-01
• Primary completion: 2027-09-30
• Completion: 2027-12-31
• First posted: 2022-05-10
• Last updated: 2025-10-03

Locations

17 sites across 1 country: United States

Regulatory

• FDA-regulated drug study