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Acetazolamide for Brain Aneurysm

Phase 4

Waitlist Available

Led By Azam Ahmed, MD

Research Sponsored by University of Wisconsin, Madison

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up pre and post perfusion during imaging procedure, up to an hour

Awards & highlights

Pivotal Trial

Drug Has Already Been Approved

No Placebo-Only Group

Summary

This trial uses a special CT scan and a drug to check brain blood flow in patients with a specific type of brain bleed. The drug should increase blood flow, and if it doesn't, it indicates a problem. This helps identify patients at risk for future brain issues like stroke.

Eligible Conditions

Migraine
Brain Aneurysm

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ pre and post perfusion during imaging procedure, up to an hour

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~pre and post perfusion during imaging procedure, up to an hour

This trial's timeline: 3 weeks for screening, Varies for treatment, and pre and post perfusion during imaging procedure, up to an hour for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Participants Who Develop Delayed Cerebral Vasospasm

Secondary study objectives

Percent Change in Left Hemisphere Brain Imaging Maps

Percent Change in Right Hemisphere Brain Imaging Maps

Relative Percent Change in Cerebral Blood Flow

Side effects data

From 2022 Phase 4 trial • 11 Patients • NCT03377049

External Ventricular Drainage infection

Hydrocephalus

Pulmonary edema

Cardiomyopathy

100%

80%

60%

40%

20%

Study treatment Arm

Acetazolamide Challenge

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Acetazolamide ChallengeExperimental Treatment1 Intervention

Participants entered into the study as a cohort, will because of their participation, undergo only two additional digital subtraction angiogram (DSA) imaging acquisitions. These will be done in conjunction with their standard diagnostic DSA evaluation and consist of two CBCTPs, one before and one after administration of 1 g acetazolamide through a peripheral IV line. Each CBCTP will require administration of 75-100 mL iodinated contrast medium also through an intravenous line. Neither of these imaging studies will be used for clinical decision making, but would be processed and evaluated at later date for a formal analysis of the results. Following completion of diagnostic imaging subjects will receive the usual standard of care for treatment of their ruptured aneurysm i.e. endovascular embolization or open surgical clipping.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Acetazolamide

2011

Completed Phase 4

~3030

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