A Study to Investigate the Effects and Safety of SPG601 for the Treatment of Fragile X Syndrome i… (NCT07439510) | Clinical Trial Compass
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 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, 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
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
1
Phase 2b: Change from baseline in Total Cognition Composite Change Sensitive Score from the NIH-TCB
Timeframe: 8 weeks
2
Phase 2b: Change from baseline in EEG resting state relative power bands during rest
Timeframe: 8 weeks
3
Phase 3:Change from baseline in Total Cognition Composite score from the NIH-TCB