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NCT01764451 · ClinicalTrials.gov registry record · Early Phase 1

Permeability MRI in Cerebral Cavernous Malformations Type 1 in New Mexico: Effects of Statins

A Early Phase 1 study, sponsored by University of New Mexico.

Terminated
Registry status
Early Phase 1
Development phase
12
Enrollment target

NCT01764451: Clinical Trial Early Phase 1 study, sponsored by University of New Mexico.

NCT01764451 is a Early Phase 1 study that was terminated before completion, run by University of New Mexico. The registered enrollment target is 12 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01764451, a Early Phase 1 study, was terminated before completion, sponsored by University of New Mexico.

TERMINATED
Registry status
Early Phase 1
Development phase
12 participants
Enrollment target

Study Summary

Cerebral cavernous malformations (CCMs) are clusters of abnormal blood vessels in the brain and spine. CCMs can bleed and cause strokes, seizures, and headaches. In some patients, CCMs affect the blood brain barrier (BBB). The BBB is the body's separation of blood and its contents in the brain from the brain tissue itself. Abnormal leakiness or permeability of this barrier can cause disease. We will measure the permeability (leakiness) of the BBB using a magnetic resonance imaging (MRI) technique called dynamic contrast-enhanced MRI (DCEMRI). The purpose of this study is to look at whether statin medications change the permeability (leakiness) of the blood brain barrier in CCM patients. Statin medications are used to lower cholesterol levels and prevent heart attack and stroke. In addition, this medication may decrease the risk of brain hemorrhage or bleeding in patients with CCM. This study will examine whether the permeability of the BBB changes following the administration of simvastatin for three months.

Primary Outcome

We will measure the change in blood brain barrier permeability with dynamic contrast enhanced MRI from baseline to three months. We will compare the change in permeability for a group of CCM patients placed on statin medication (treatment group) with a group of CCM patients not on statin medication (control group).

Interventions

  • DRUG Simvastatin

Trial Details

FieldValue
Enrollment Target 12 participants
Start Date 2012-03
Est. Completion 2016-01
Phase Early Phase 1
University of New Mexico

168 total trials

Why NCT01764451 stopped before completion

NCT01764451 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (77% lower).

The record links to 0 conditions, and to 1 intervention - of which Simvastatin is the first listed.

NCT01764451 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01764451 about?

NCT01764451 is a clinical study titled "Permeability MRI in Cerebral Cavernous Malformations Type 1 in New Mexico: Effects of Statins". Cerebral cavernous malformations (CCMs) are clusters of abnormal blood vessels in the brain and spine. CCMs can bleed and cause strokes, seizures, and headaches. In some patients, CCMs affect the blood brain barrier (BBB). The BBB is the body's separation of blood and its contents in the brain from ...

What is the current status of trial NCT01764451?

This trial is currently terminated. It is a Early Phase 1 study. The enrollment target is 12 participants. The study started on 2012-03. Estimated completion is 2016-01.

What interventions are being tested in trial NCT01764451?

The interventions under investigation include: Simvastatin (DRUG).

Who is sponsoring clinical trial NCT01764451?

This trial is sponsored by University of New Mexico, which has 168 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01764451's enrollment target sits among peer trials

12 1529th of 2000 higher than 401 of 2,000 other Early Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01764451, the US trial registry maintained by the National Library of Medicine. NCT01764451 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.