CompletedPhase 2

Study of SPG601 in Adult Men With Fragile X Syndrome

United States10 participantsStarted 2024-07-05

Plain-language 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.

Who can participate

Age range

18 Years – 45 Years

Sex

MALE

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 * 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 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 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Clinical Global Impressions Improvement Scale as Determined by the Treating Clinician

Timeframe: 15 days

Clinical Global Impressions Improvement Scale as Determined by the Caregiver

Timeframe: 15 days

Visual Analog Scale as Determined by the Patient Caregiver

Timeframe: 15 days

Change in Auditory Response to Chirp Stimulus

Timeframe: 15 days

Trial details

NCT IDNCT06413537

SponsorSpinogenix

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-12-31

Results submitted2025-12-11

View on ClinicalTrials.gov More Fragile X Syndrome trials

Who can participate

Age range

18 Years – 45 Years

Sex

MALE

See this in plain English?

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

What they're measuring

Clinical Global Impressions Improvement Scale as Determined by the Treating Clinician

Timeframe: 15 days

Clinical Global Impressions Improvement Scale as Determined by the Caregiver

Timeframe: 15 days

Visual Analog Scale as Determined by the Patient Caregiver

Timeframe: 15 days

Change in Auditory Response to Chirp Stimulus

Timeframe: 15 days