clinical trial · NCT05163808
A Randomized Study of BPN14770 in Male Adolescents (Aged 9 to < 18 Years) With Fragile X Syndrome
Tetra Discovery Partners·phase3·completed·n = 163
Fragile X SyndromezatolmilastPlacebo
brief 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).
started
Mar 29, 2022
primary completion
Sep 2, 2025
completion
Sep 2, 2025
last updated
Feb 4, 2026
detailed 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.
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
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol