NCT07439510Not yet recruitingPhase 2/3
A Study to Investigate the Effects and Safety of Codabakalner for the Treatment of FXS in Male Participants and Adult Participants With ADS
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
Source: ClinicalTrials.gov · Last updated 9 Oct 2026
Brief summary (registry, in English)
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
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- First submitted
- 18 Feb 2026
- Start date
- 1 Dec 2026
- Primary completion date
- 1 Feb 2030
- Lead sponsor
- Spinogenix
- Diseases
- Autism
- NCT number
- NCT07439510
What you commit to
- Study type: Interventional · Phase 2/3
- Planned participants: 120
- From 1 Dec 2026 to the primary completion date, 1 Feb 2030
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Other investigational products within 30 days
Other illness
- Any physical or psychological condition that prohibits study completion
- Uncontrolled seizures or history of epilepsy with a seizure in the past 6 months.
- History of suicidal behaviour or suicidal ideation
- History of substance abuse or dependence within 6 months
Other
- Auditory or visual impairments that cannot be corrected
- Screening vital signs that are abnormal per protocol specification
- ECG that are abnormal and clinically significant
- Unable to swallow capsules
Who the study is looking for
- Phase 2b: Adult males aged 18 to 45 years, inclusive Phase 3: Males aged 13-45 years, inclusive Mental age \>/= 36mon
- Diagnosis of Fragile X as confirmed with genetic testing and Stanford Binet testing or
- Confirmed diagnosis ASD per DSM5-TR and EEG criteria
- Patient must have caregiver
- Must be in good health with no significant medical history
Age in the registry: 18 years to 45 years · Sex: Male · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.