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Could a sublingual tablet repair the Brain's leaky barrier in CADASIL?

NCT ID NCT07692399

Disease control Sponsor: Huashan Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 09, 2026 · Last updated Jul 10, 2026 · Updated 1 time

Summary

This trial investigates whether edaravone dexborneol sublingual tablets can improve blood-brain barrier function in people with CADASIL, a genetic condition that causes small strokes and cognitive decline. About 60 adults aged 18 to 80 with confirmed CADASIL will be observed for 6 months without the drug, then take the tablet twice daily for another 6 months. The study measures changes in brain barrier health using MRI and tracks stroke events, thinking skills, and safety.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
edaravone dexborneol sublingual tablets
What this could lead to
If it works, this could point toward a treatment that slows brain damage and lowers stroke risk in people with CADASIL.
What could go wrong
This is a small, early-phase trial with no placebo group, so results may not be conclusive. The drug may not improve outcomes or could cause side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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). Exclusion Criteria: * 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.

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Conditions

The condition(s) this trial relates to.

cerebral arteriopathy with subcortical infarcts and leukoencephalopathy cerebral arteriopathy, autosomal dominant, with subcortical infarcts and leukoencephalopathy, type 1

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cadasil

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Huashan Hospital, Fudan University

    Shanghai, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.