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mTOR inhibitor

Sirolimus for Brain Aneurysm

Phase 2
Recruiting
Led By Robert M Starke, M.D.
Research Sponsored by University of Miami
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Undergoing one of the following procedures at Jackson Memorial Hospital: Clipping of an unruptured cerebral artery aneurysm, Endovascular treatment of unruptured cerebral aneurysms (including those receiving coiling)
≥ 18 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 18
Awards & highlights

Study Summary

This trial will test if Sirolimus can help treat cerebral aneurysms by correcting the underlying molecular changes.

Who is the study for?
This trial is for adults over 18 who are getting surgery or endovascular treatment for unruptured brain aneurysms at Jackson Memorial Hospital and can consent to participate. It's not for those with HIV, certain types of aneurysms, pregnant or breastfeeding women, severe psychiatric conditions, skin cancer history, sirolimus allergy, serious illnesses affecting study results, lung disease called interstitial pneumonitis, or kidney/liver failure.Check my eligibility
What is being tested?
The trial studies the effect of Sirolimus on brain aneurysm molecular changes. Participants will receive either microsurgical clipping or endovascular treatment along with Sirolimus to see how it influences the condition at a molecular level.See study design
What are the potential side effects?
Sirolimus may cause side effects like increased risk of infection due to immune system suppression, potential lung problems (interstitial pneumonitis), allergic reactions in those sensitive to it and could worsen existing liver or kidney issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am scheduled for a procedure at Jackson Memorial Hospital to treat an unruptured brain aneurysm.
Select...
I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 18
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 18 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Body Weight Changes
Change in gene expression from control arteries.
Change in gene expression.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Microsurgical Clipping Treated with SirolimusExperimental Treatment2 Interventions
Participants undergoing standard of care microsurgical clipping of unruptured cerebral aneurysm will be treated with 2 mg Sirolimus daily for 14-18 consecutive days prior to surgery.
Group II: Endovascular Treatment Treated with SirolimusExperimental Treatment2 Interventions
Participants undergoing standard of care endovascular treatment of unruptured cerebral aneurysm procedure will be treated with 2 mg Sirolimus daily for 14-18 consecutive days prior to procedure.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sirolimus
2013
Completed Phase 4
~2750
Endovascular treatment
2017
Completed Phase 1
~500

Find a Location

Who is running the clinical trial?

National Institute of Neurological Disorders and Stroke (NINDS)NIH
1,341 Previous Clinical Trials
649,309 Total Patients Enrolled
University of MiamiLead Sponsor
902 Previous Clinical Trials
409,996 Total Patients Enrolled
Robert M Starke, M.D.Principal InvestigatorUniversity of Miami

Media Library

Sirolimus (mTOR inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04141020 — Phase 2
Brain Aneurysm Research Study Groups: Microsurgical Clipping Treated with Sirolimus, Endovascular Treatment Treated with Sirolimus
Brain Aneurysm Clinical Trial 2023: Sirolimus Highlights & Side Effects. Trial Name: NCT04141020 — Phase 2
Sirolimus (mTOR inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04141020 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants have enrolled in this research initiative?

"Affirmative. According to clinicaltrials.gov, this medical examination is actively seeking participants since it was first posted on October 27th 2021 and last updated on September 9th 2022. 80 volunteers are needed from a single centre of research."

Answered by AI

Have there been prior investigations involving Sirolimus?

"Presently, 125 trials are being conducted in regard to Sirolimus with 13 of those at Phase 3. Though Cincinnati, Ohio is hosting many studies for this drug, clinical trials involving it can be found at a total of 1074 sites worldwide."

Answered by AI

What medical conditions has Sirolimus been known to alleviate?

"Sirolimus is typically prescribed to ward off organ rejection, particularly in transplant and liver cases. Additionally, it can be utilized as a remedy for various conditions, including kidney disease and renal angiomyolipomas."

Answered by AI

Is there still availability for participants in this experiment?

"Based on the information available on clinicaltrials.gov, this research project is still open to participants and was last updated in September of 2022. The study opened its doors for enrolment on October 27th 2021."

Answered by AI

To what degree can Sirolimus be deemed hazardous to the health of a patient?

"Our team assessed the safety of Sirolimus as a 2, due to limited evidence backing its efficacy but some supporting its security during Phase 2 trials."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Effect of Sirolimus on Molecular Alterations in Cerebral Aneurysms
Robert Starke 2021. "Effect of Sirolimus on Molecular Alterations in Cerebral Aneurysms". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04141020.
~40 spots leftby Nov 2026
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