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Iron Chelating Agent

Deferiprone for Subarachnoid Hemorrhage

Phase 1 & 2

Recruiting

Led By David Hasan, MD

Research Sponsored by David Hasan

Eligibility Criteria Checklist

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

Must have

Location and pattern of the SAH must have the majority of the SAH in the supratentorial space caused by either an intradural anterior circulation aneurysm or a basilar apex/posterior circulation aneurysm with primarily supratentorial hemorrhage extension

Age greater than or equal to 18 and less than or equal to 75 years

Must not have

Immunosuppression therapy including chronic corticosteroid usage

Remote history of previous ruptured cerebral aneurysm

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 6 weeks, and 6 and 12 months

Summary

This trial will help assess if De + standard of care can help improve outcomes in SAH patients by reducing iron deposition and ferritin levels in the brain.

Who is the study for?

This trial is for adults aged 18-75 with recent subarachnoid hemorrhage (SAH) due to a ruptured cerebral aneurysm, who've had successful aneurysm treatment and are stable. Excluded are those with certain types of SAH, previous major health events or surgeries, severe infections, significant other brain issues, uncontrolled hypertension, known allergies to the study drug Deferiprone, or contraindications for MRI.

What is being tested?

The trial tests if Deferiprone pills can reduce iron in the brain and improve thinking skills after SAH. Participants will either receive Deferiprone plus standard care or a placebo plus standard care. The effects will be measured by checking ferritin levels in spinal fluid and cognitive function using the Montreal Cognitive Assessment.

What are the potential side effects?

Deferiprone may cause side effects like nausea, vomiting, joint pain and changes in liver enzymes. There's also a risk of neutropenia (a drop in white blood cells), which could increase infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My brain hemorrhage is mostly in the upper part of my brain, caused by a specific type of aneurysm.

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I am between 18 and 75 years old.

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I was fully independent before my brain hemorrhage.

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My aneurysm has been treated with coils and is fully or mostly secured.

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My CT scan shows a brain bleed due to a burst aneurysm.

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My brain hemorrhage is not the most severe according to a specific scale.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am on long-term immunosuppression therapy or taking chronic corticosteroids.

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I had a brain aneurysm burst in the past.

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I had surgery to clip a burst or unburst aneurysm before joining this study.

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My SAH is not due to a burst aneurysm but was identified as traumatic or a specific type by a special scan.

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I need additional medication to prevent blood clots due to my aneurysm treatment.

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My blood pressure is very high and cannot be controlled before joining.

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I have not had major surgery in the last 30 days.

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I haven't had major bleeding, severe liver issues, or serious kidney problems recently.

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I have untreated aneurysms that could have caused my bleeding in the brain.

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I had a heart issue after a brain hemorrhage, needing drugs for blood pressure or have a low heart pump rate.

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I do not have a condition that requires draining fluid from my brain.

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I have a history of seizures or epilepsy and have been advised to take anti-epileptic medication.

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I have a stent or device in my brain for an aneurysm and need medication to prevent blood clots.

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I have a new brain bleed or stroke larger than 15ml, or my recent brain scans show significant swelling compared to earlier ones.

Select...

I have been diagnosed with sepsis or have an active infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 6 weeks, and 6 and 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 6 weeks, and 6 and 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 6 weeks, and 6 and 12 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Ferritin levels in cerebrospinal fluid

Secondary study objectives

Assess functional outcomes

Change in Modified Rankin Scale (mRS) score

Change in amygdala measured size

+5 more

Side effects data

From 2013 Phase 4 trial • 32 Patients • NCT01770652

13%

Headache

100%

80%

60%

40%

20%

Study treatment Arm

Severe Renal Impairment

Normal Hepatic Function (Healthy Volunteers)

Mild Renal Impairment

Moderate Renal Impairment

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: DeferiproneExperimental Treatment2 Interventions

This is the drug arm (deferiprone). Patients will receive oral deferiprone

Group II: ControlPlacebo Group2 Interventions

this group will only receive the placebo (sugar pill)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Montreal Cognitive Assessment

2019

N/A

~240

0 / 21Eligibility criteria met

Find a Location

Who is running the clinical trial?

David HasanLead Sponsor

3 Previous Clinical Trials

63 Total Patients Enrolled

Duke UniversityLead Sponsor

2,462 Previous Clinical Trials

2,968,854 Total Patients Enrolled

20 Trials studying Dementia

41,653 Patients Enrolled for Dementia

David Hasan, MD5.02 ReviewsPrincipal Investigator - Duke University

University of Iowa

1 Previous Clinical Trials

33 Total Patients Enrolled

5Patient Review

I had complications after brain surgery for Acoustic neuroma but thankful to have Dr. Hasan to save my life with VP Shunt. I would highly recommend him!