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Clinical Trial Summary

This Phase 2 study described herein will evaluate the safety, efficacy, tolerability, pharmacokinetics and pharmacodynamics of SPG601 in adult men with Fragile X syndrome.


Clinical Trial Description

This study is a Phase 2 randomized, double blind, placebo-controlled, cross over, single dose of SPG601 and matching Placebo in patients with Fragile X syndrome. This study will entail 2 in person clinic visits to administer oral doses of SPG601 or matching placebo. Participants will receive a dose of either SPG601 or placebo at first visit, and will cross over to receive the other product at the second visit. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06413537
Study type Interventional
Source Spinogenix
Contact Sarah Richter
Phone 513-803-3324
Email sarah.richter@cchmc.org
Status Recruiting
Phase Phase 2
Start date June 18, 2024
Completion date February 2025

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