Clinical Trial

A Study to Investigate the Effects and Safety of SPG601 for the Treatment of Fragile X Syndrome in Male Participants

Not Yet Recruiting Phase 2/3
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Summary
This Phase 2b/3, randomized, double-blind, placebo-controlled, 2-part study will evaluate the efficacy, safety and tolerability of different dose regimens of SPG601 in adult male participants with Fragile X syndrome.
Trial Details
NCT Number NCT07439510
Lead Sponsor Spinogenix
Conditions Fragile X Syndrome (FXS)
Enrollment 248 participants
Start Date 2026-03-01
Primary Completion 2030-02-01 (estimated)
Study Completion 2030-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-02-27