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ACTIVE NOT RECRUITING
NCT05367960
PHASE3

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

Sponsor: Tetra Discovery Partners

View on ClinicalTrials.gov

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).

Key Details

Gender

MALE

Age Range

9 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

314

Start Date

2022-11-01

Completion Date

2027-12-31

Last Updated

2025-10-03

Healthy Volunteers

No

Interventions

DRUG

Zatolmilast/ BPN14770

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

Locations (17)

Amnova Clinical Research

Irvine, California, United States

Thompson Autism & Neurodevelopment Center - CHOC

Orange, California, United States

MIND Institute UC Davis Medical Center

Sacramento, California, United States

Children's Hospital Colorado

Aurora, Colorado, United States

University of Miami

Miami, Florida, United States

Emory University School of Medicine

Atlanta, Georgia, United States

Rush University Medical Center

Chicago, Illinois, United States

University of Kansas Medical Center

Kansas City, Kansas, United States

Kennedy Krieger Institute

Baltimore, Maryland, United States

Boston Children's Hospital

Boston, Massachusetts, United States

U Mass

Worcester, Massachusetts, United States

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Suburban Research Associates

Media, Pennsylvania, United States

Clinic for Special Children

Strasburg, Pennsylvania, United States

Greenwood Genetic Center

Greenville, South Carolina, United States

University of Utah and Primary Children's Hospital

Salt Lake City, Utah, United States