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NOT YET RECRUITING
NCT07439510
PHASE2/PHASE3
A Study to Investigate the Effects and Safety of SPG601 for the Treatment of Fragile X Syndrome in Male Participants
Sponsor: Spinogenix
View on ClinicalTrials.gov
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.
Official title: A Phase 2b/3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of SPG601 in Male Participants With Fragile X Syndrome
Key Details
Gender
MALE
Age Range
18 Years - 45 Years
Study Type
INTERVENTIONAL
Enrollment
248
Start Date
2026-03-01
Completion Date
2030-06-30
Last Updated
2026-02-27
Healthy Volunteers
No
Conditions
Interventions
DRUG
SPG601
synthetic small molecule
DRUG
Placebo
Placebo