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Back-Drain drug may stop brain artery spasms after aneurysm rupture

NCT ID NCT07246629

Prevention Sponsor: Wake Forest University Health Sciences Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 31, 2026 · Updated 2 times

Summary

This study tests whether giving a calcium channel blocker (nicardipine) through a lumbar drain can prevent dangerous artery spasms and delayed brain damage in people who have had a brain bleed from a ruptured aneurysm. About 214 adults with mild to moderate bleeds will receive the drug or a placebo through the drain. The goal is to see if this approach reduces the risk of vasospasm and improves recovery.

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 214 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Mar 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: * Age ≥18 years * Aneurysmal subarachnoid hemorrhage with Hunt and Hess score 3 or less * Patient or legal authorized representative available to sign the informed consent form * Pre-morbid modified Rankin scale of 0 or 1. * Patients who have lumbar drain placed or planned for cerebrospinal fluid diversion per standard of care * Patients who are able to be randomized within 72 hours from arrival with aneurysmal subarachnoid hemorrhage or within 24 hours from lumbar drain placement Exclusion Criteria: * Pregnant females * Subarachnoid hemorrhage (SAH) with hunt and hess scale of \>3 * SAH due to etiology other than aneurysmal rupture * Any contraindications in patients receiving calcium channel antagonists like hypersensitivity to dihydropyridines * Active central nerve infection (CNS) infection or high suspicion of CNS infection * Hemodynamic instability preventing the use of Nicardipine

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Conditions

The condition(s) this trial relates to.

acquired aneurysmal subarachnoid hemorrhage brain aneurysm subarachnoid hemorrhage intracranial vasospasm prevention target

As listed by the trial registrant

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

Subarachnoid hemorrhage

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

  • Advocate Lutheran General Hospital

    Park Ridge, Illinois, 60068, United States

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