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Completed Phase 2Phase 3 Interventional

A Randomized Study of BPN14770 in Male Adolescents (Aged 9 to < 18 Years) With Fragile X Syndrome

ClinicalTrials.gov ID: NCT05163808

Public ClinicalTrials.gov record NCT05163808. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 2, 2026, 5:50 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Randomized, Double-blind, Placebo-controlled, Two-Part Study of BPN14770 in Male Adolescents (Aged 9 to < 18 Years) With Fragile X Syndrome

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This is a 2-part study, with each part having a unique set of objectives for male adolescents aged 9 to \< 18 years with fragile X syndrome (FXS). Part 1 is an open-label, single-dose, pharmacokinetics (PK) assessment of BPN14770 25 mg and 50 mg, while Part 2 is double-blind (DB) and randomized between two treatment groups (Study Drug and Placebo).

Study identification

NCT ID
NCT05163808
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2, Phase 3
Lead sponsor
Tetra Discovery Partners
Industry
Enrollment
163 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
9 Years to 18 Years
Sex
Male
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Mar 28, 2022
Primary completion
Sep 1, 2025
Completion
Sep 1, 2025
Last update posted
Aug 30, 2026

2022 – 2025

United States locations

U.S. sites
17
U.S. states
13
U.S. cities
17
Facility City State ZIP Site status
Amnova Clinical Research Irvine California 92604
Thompson Autism & Neurodevelopment Center - CHOC Orange California 92868
UC Davis Sacramento California 95817
Children's Hospital Colorado Aurora Colorado 80045
University of Miami Miami Florida 33136
Emory University School of Medicine Atlanta Georgia 30322
Rush University Medical Center Chicago Illinois 60612
University of Kansas Medical Center Kansas City Kansas 66160
Kennedy Krieger Institute Baltimore Maryland 21205
Boston Children's Hospital Boston Massachusetts 02115
U Mass Worcester Massachusetts 01655
Icahn School of Medicine at Mount Sinai Hospital New York New York 10029
Cincinatti Children's Hospital Medical Center Cincinnati Ohio 45229
Suburban Research Associates Media Pennsylvania 19063
Clinic for Special Children Strasburg Pennsylvania 17579
Greenwood Genetic Center Greenville South Carolina 29605
University of Utah and Primary Childrens Hospital Salt Lake City Utah 84113

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05163808, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Aug 30, 2026 · Synced Sep 2, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT05163808 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →