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NOT YET RECRUITING
NCT07439510
PHASE2/PHASE3
A Study to Investigate the Effects and Safety of Codabakalner for the Treatment of FXS in Male Participants and Adult Participants With ADS
Sponsor: Spinogenix
View on ClinicalTrials.gov
Summary
This is a Study to Investigate the Effects and Safety of Codabakalner for the Treatment of Fragile X Syndrome in Male Participants and Adult Participants with Autism Spectrum Disorders
Official title: A Phase 2b/3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Codabakalner in Male Participants With Full Mutation Fragile X Syndrome and Adult Participants With Autism Spectrum Disorders
Key Details
Gender
MALE
Age Range
18 Years - 45 Years
Study Type
INTERVENTIONAL
Enrollment
120
Start Date
2026-12-01
Completion Date
2030-06-30
Last Updated
2026-10-09
Healthy Volunteers
No
Interventions
DRUG
Codabakalner
synthetic small molecule
DRUG
Placebo
Placebo