A Randomized, Double-blind, Placebo-controlled, Parallel Group Study of BPN14770 in Male Adults (Aged 18 to 45) with Fragile X Syndrome
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
171
25mg BID BPN14770
Placebo
Amnova Clinical Research
Irvine, California, United States
Thompson Autism & Neurodevelopment Center - CHOC
Orange, California, United States
National Institutes of Health Toolbox Cognitive Battery cognition crystallized composite score (NIH-TCB CCC)
National Institutes of Health Toolbox Cognitive Battery cognition crystallized composite score (NIH-TCB CCC), which is calculated from the Picture Vocabulary and Oral Reading domains.
Time frame: 13 Weeks
Numerical rating scale (NRS) scores based on subject-specific behaviors vs baseline
Numerical rating scale (NRS) scores based on subject-specific behaviors within the domains of Daily Function and Language
Time frame: 13 Weeks
Caregiver Global Impression of Improvement (CaGI-I)
Caregiver Global Impression of Improvement (CaGI-I) for the general domains of Daily Function and Language
Time frame: 13 Weeks
Clinical Global Impression Improvement (CGI-I) for - Investigator
Clinical Global Impression Improvement (CGI-I) for - Investigator rated the general domains of Daily Function and Language
Time frame: 13 Weeks
Vineland-3 Adaptive Behavior Scale (Vineland-3)
Vineland-3 Adaptive Behavior Scale (Vineland-3), using the composite score and domain scores from communication, daily living skills, and socialization
Time frame: 13 Weeks
Verbal Knowledge test from the Stanford-Binet (ed 5) (SB-5)IQ
Verbal Knowledge test from the Stanford-Binet (ed 5) (SB-5) IQ assessment
Time frame: 13 Weeks
NIH-TCB domains of Picture Sequence Memory, Flanker Inhibitory Control and Attention, List Sorting Working Memory, Dimensional Change Card Sort, and Speeded Matching
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UC Davis Health System
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
...and 7 more locations
NIH-TCB domains of Picture Sequence Memory, Flanker Inhibitory Control and Attention, List Sorting Working Memory, Dimensional Change Card Sort, and Speeded Matching
Time frame: 13 Weeks
Aberrant Behavior Checklist (ABC) scores
Aberrant Behavior Checklist (ABC) scores
Time frame: 13 Weeks
Anxiety, Depression, and Mood Scale (ADAMS) scores
Anxiety, Depression, and Mood Scale (ADAMS) scores
Time frame: 13 Weeks