NCT07692399 · Phase 2 · NOT YET RECRUITING
Safety and Efficacy of Edaravone Dexborneol Sublingual Tablets for Blood-Brain Barrier Dysfunction in CADASIL
This trial tests whether edaravone dexborneol, a tablet dissolved under the tongue, improves how well the blood-brain barrier works in people with CADASIL, an inherited small-vessel brain disease. Researchers track this with a special MRI scan. It is a Phase 2 trial, testing safety and whether it works, not yet proven or approved.
You may qualify if
- 1. Genetically Confirmed CADASIL: Diagnosis of CADASIL confirmed by NOTCH3 genetic testing.
- 2. Age: Between 18 and 80 years.
- 3. Lacunar Lesion Requirement: Presence of ≥1 lacune on brain MRI.
- 4. No acute ischemic stroke or intracerebral hemorrhage within the past 3 months.
- 5. Modified Rankin Scale (mRS) score of 0 to 3.
- 6. Contraception Requirements: Women of childbearing potential and male participants with female partners of childbearing potential must agree to use effective contraception during the study and 30 days after the last dose of the investigational drug.Female participants must have a negative pregnancy test before enrollment.
- 7. Informed Consent: Participants or their legal representatives must voluntarily sign an informed consent form (ICF).
You're excluded if
- 1. Presence of other major neurological disorders: Non-vascular white matter diseases (e.g., multiple sclerosis, carbon monoxide encephalopathy), central nervous system infections, Creutzfeldt-Jakob disease, primary Parkinson's disease, traumatic brain injury, or intracranial tumors.
- 2. Severe Liver Dysfunction: Active liver disease (acute hepatitis, chronic active hepatitis, cirrhosis) or ALT/AST >2× ULN.
- 3. Severe renal impairment (serum creatinine >1.5× ULN).
- 4. Life Expectancy \<1 year due to severe systemic diseases.
- 5. Contraindications to MRI: Participants with MRI-incompatible implants, severe claustrophobia, or inability to undergo MRI.
- 6. Known Allergies: History of hypersensitivity to Dexborneol, natural borneol, edaravone, or any excipients (e.g., mannitol, copovidone, microcrystalline cellulose, silica, magnesium stearate).
- 7. Pregnancy and Lactation: Pregnant or lactating women, or those planning pregnancy during the study period.
- 8. Participation in Other Clinical Trials
- 9. Other Investigator-Determined Factors: Any other medical, psychological, or social condition that, in the investigator's judgment, makes the patient unsuitable for participation.
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2026-07-09