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

Starting soon · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Fragile X Syndrome (FXS)

In brief

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.

Key facts

Study ID

NCT07439510

Run by

Spinogenix

People needed

248

Starts

2026-03-01

Expected to finish

2030-06-30

Last updated by the study team

2026-02-27

Who can join

Age: 18 and older, up to 45. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Adult males aged 18 to 45 years, inclusive
• Diagnosis of Fragile X as confirmed with genetic testing
• Patient must have caregiver
• Must be in good health with no significant medical history

You may not qualify if…

• Any physical or psychological condition that prohibits study completion
• Uncontrolled seizures or history of epilepsy with a seizure in the past 6 months.
• Auditory or visual impairments that cannot be corrected
• History of suicidal behavior or suicidal ideation
• Screening vital signs that are abnormal per protocol specification
• ECG that are clinically significant abnormal
• History of substance abuse or dependence within 6 months
• Other investigational products within 30 days
• Unable to swallow capsules

Full record on ClinicalTrials.gov

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