Not Yet RecruitingPhase 2/3

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

248 participantsStarted 2026-03-01

Plain-language 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.

Who can participate

Age range18 Years – 45 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * 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

What they're measuring

Phase 2b: Change from baseline in Total Cognition Composite Change Sensitive Score from the NIH-TCB

Timeframe: 8 weeks

Phase 2b: Change from baseline in EEG resting state relative power bands during rest

Timeframe: 8 weeks

Phase 3:Change from baseline in Total Cognition Composite score from the NIH-TCB

Timeframe: 12 weeks

Trial details

NCT IDNCT07439510

SponsorSpinogenix

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2030-02-01

Contact for this trial

Contact

(503) 673-3842 contact@spinogenix.com

View on ClinicalTrials.gov More Fragile X Syndrome (FXS) trials