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Could a common drug prevent brain swelling after stroke?

NCT ID NCT07528456

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether the drug butylphthalide can reduce brain swelling in people who have had a severe stroke and undergone a procedure to reopen a blocked artery. About 100 adults will receive either the drug or a placebo for up to 14 days. Researchers will measure changes in spinal fluid and brain scans to see if the drug helps.

What this could mean

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

Active substance
butylphthalide
What this could lead to
If it works, this could point toward a new way to reduce dangerous brain swelling after a stroke, potentially improving recovery.
What could go wrong
This is a small, early-phase trial with only 100 people. The drug may not reduce swelling better than placebo, and side effects are possible.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 100 people

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

Expected to start

Apr 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 years and older

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. Age ≥18 years. 2. Time from onset to randomization within 24 hours. 3. Confirmed occlusion of the internal carotid artery or the M1 segment of the middle cerebral artery by digital subtraction angiography (DSA). 4. NIHSS score ≥10 at onset, or NIHSS score \>8 at 1 hour post-procedure (for those able to cooperate with NIHSS assessment), or CT-ASPECTS score 3-7 immediately post-procedure. 5. Received endovascular treatment with successful reperfusion (mTICI ≥2b). 6. Signed informed consent form by the subject or their legally authorized representative. Exclusion Criteria: 1. Pre-stroke modified Rankin Scale (mRS) score ≥2. 2. Immediate post-procedure CT indicating PH2 hemorrhagic transformation or subarachnoid hemorrhage. 3. Immediate post-procedure CT indicating cerebral herniation or planned decompressive craniectomy. 4. History or evidence of intracerebral hemorrhage, subarachnoid hemorrhage, arteriovenous malformation, cerebral aneurysm, or brain tumor. 5. Evidence (clinical or radiological) of concurrent infarction in the contralateral cerebral hemisphere that, in the investigator's judgment, may affect functional prognosis. 6. Clinical or radiological evidence of vertebral or basilar artery occlusion. 7. History of severe renal impairment (e.g., on dialysis) or estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73 m²; severe hepatic disease or alanine aminotransferase (ALT) \>3× the upper limit of normal, or total bilirubin \>2× the upper limit of normal. 8. Use of butylphthalide within 7 days prior to enrollment. 9. Known allergy to butylphthalide. 10. Pregnancy. 11. Breastfeeding women who do not agree (or whose legally authorized representative does not allow) to discontinue breastfeeding during the study drug administration period and for 7 days thereafter. 12. Participation in other purely observational stroke studies, or expected survival \<6 months unrelated to the current stroke, or unlikely to comply with follow-up requirements. 13. Currently receiving another investigational drug with the same or similar mechanism of action as the study drug. 14. Any condition that, in the investigator's opinion, makes the subject unsuitable for participation in the study.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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

  1. The places running it

    10 sites. 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

  • Dongguan People's Hospital

    Dongguan, Guangdong, China

  • Ganzhou People's Hospital

    Ganzhou, Jiangxi, China

  • Haikou People's Hospital

    Haikou, Hainan, China

  • Hainan Provincial Hospital of Traditional Chinese Medicine

    Haikou, Hainan, China

  • Heyuan People's Hospital

    Heyuan, Guangdong, China

  • Nanfang Hospital of Southern Medical University

    Guangzhou, Guangdong, 510515, China

  • Qingyuan People's Hospital

    Qingyuan, Guangdong, China

  • The Fourth Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong, China

  • The Second Affiliated Hospital of Hainan Medical University

    Haikou, Hainan, China

  • Yuebei People's Hospital

    Shaoguan, Guangdong, China

More trials for these conditions

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