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

NCT05367960 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 314

Last updated 2025-10-03

No results posted yet for this study

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).

Conditions

  • Fragile X Syndrome

Interventions

DRUG

Zatolmilast/ BPN14770

25mg zatolmilast/BPN14770 (Adults) or 15 mg zatolmilast/BPN14770 (Adolescents \<43 kg)

Sponsors & Collaborators

  • Tetra Discovery Partners

    lead INDUSTRY

Principal Investigators

  • Elizabeth Berry-Kravis, MD · Rush University Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
9 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-01
Primary Completion
2027-09-30
Completion
2027-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05367960 on ClinicalTrials.gov