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

Fragile X Syndrome Clinical Trial

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

Clinical Trial Summary

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).

Clinical Trial Description

In amendment 4 the enrollment age range what changed to allow enrollment in participants as young as 9 years of age. This only affects Part 2 as Part 1 was completed prior to this amendment. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05163808
Study type Interventional
Source Tetra Discovery Partners
Contact CEO
Phone 616-224-0084
Email info@tetratherapeutics.com
Status Recruiting
Phase Phase 2/Phase 3
Start date March 29, 2022
Completion date July 2024
View Details
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