The primary objective of this study is to evaluate the effect of GTX-102 in cognitive function in participants with deletion-type Angelman Syndrome (AS).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
129
Change from Baseline in Bayley-4 Cognitive Raw Score Without Caregiver Input at Day 338
Time frame: Baseline, Day 338
Net Response in Multidomain Responder Index (MDRI)
Time frame: Day 338
Change from Baseline in ABC-C Hyperactivity/Noncompliance Subscale Score at Day 338
Time frame: Baseline, Day 338
Change from Baseline in Bayley-4 Receptive Communication Raw Score at Day 338
Time frame: Baseline, Day 338
Change from Baseline in Angelman Severity Assessment (ASA) Sleep Rating Raw Score at Day 338
Time frame: Baseline, Day 338
Change from Baseline in Vineland Adaptive Behavior Scales-3 (Vineland-3) Receptive Communication Raw Score at Day 338
Time frame: Baseline, Day 338
Change from Baseline in Vineland-3 Expressive Communication Raw Score at Day 338
Time frame: Baseline, Day 338
Change from Baseline in Bayley-4 Gross Motor Raw Score at Day 338
Time frame: Baseline, Day 338
Change from Baseline in ASA Gross Motor Rating at Day 338
Time frame: Baseline, Day 338
Number of Participants with Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs), Severity of AEs and Relationship to Investigational Drug, Procedure, and Premedication
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Cedars Sinai
Los Angeles, California, United States
UCSD, Rady Children's Hospital
San Diego, California, United States
UCSF
San Francisco, California, United States
Children's Hospital Colorado
Aurora, Colorado, United States
Nicklaus Children's Hospital
Miami, Florida, United States
Rare Disease Research
Atlanta, Georgia, United States
Rush University
Chicago, Illinois, United States
Boston Children's Hospital
Boston, Massachusetts, United States
Children's Mercy
Kansas City, Missouri, United States
Columbia University Medical Center
New York, New York, United States
...and 18 more locations
Time frame: 2 Years