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An Open-Label Extension Study of BPN14770 in Subjects With Fragile X Syndrome
Sponsor: Tetra Discovery Partners
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
Conditions
Interventions
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