Study of SPG601 in Adult Men With Fragile X Syndrome

Completed · Phase 2 · Has a placebo group

Conditions studied: Fragile X Syndrome

In brief

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

Key facts

Study ID

NCT06413537

Run by

Spinogenix

People needed

10

Starts

2024-07-05

Expected to finish

2024-12-31

Last updated by the study team

2026-05-26

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
• Diagnosis of Fragile X as confirmed with genetic testing
• Patient must have caregiver
• Must be in good health with no significant medical history
• Clinical laboratory values within normal range or < 1.2 times ULN
• Contraceptive use by men or women consistent with local regulations
• Able and willing to provide written informed consent
• Stable dosing of psychotropic drugs for at least 4 weeks

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 can not 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

Where it is running

• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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