Cavernous Angioma, FamilialEarly Phase 1NCT01764451
Permeability MRI in Cerebral Cavernous Malformations Type 1 in New Mexico: Effects of Statins
A Early Phase 1 study testing Simvastatin in people with Cavernous Angioma, Familial and Cerebral Cavernous Malformations, run by University of New Mexico at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cavernous Angioma, Familial, Cerebral Cavernous Malformations, Cerebral Cavernous Hemangioma
- What is being tested?
- Simvastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2012to Jan 2016
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of cerebral cavernous malformations-common Hispanic mutation (CCM1-CHM)
- Must be willing to travel to the University of New Mexico in Albuquerque, NM for 5 visits over the course of three months.
Who cannot join
- Incarceration
- Unable to pass MRI safety screening (pregnant females, claustrophics, or those with certain metallic items implanted in their bodies)
- Low kidney function or transplants, an eGFR below 60 mL/min
- Currently taking statin medications or have taken statin medications in the past 6 months
- Known allergy or intolerance to statins
- Known allergy or intolerance to gadolinium
Show all 11Show fewer
- Liver dysfunction at baseline, AST > 47 and/or ALT > 49
- Consumption of large quantities of alcohol, men who consume more than 2 daily drinks and women who consume more than one daily drink
- CK level of 232 or higher
- Triglycerides greater than or equal to 500.
- Medications: gemfibrozil, cyclosporine, danazol, itraconazole, ketoconazole, posaconazole, ethromycin, clarithomycin, telithromycin, HIV protease inhibitors, nefazoldone, amiodarone, verapamil, dilitiazem, amlodipine, or ranalazine
Trial locations and contacts
1 site in 1 country.
United States1 site
University of New Mexico Health Sciences Center
Albuquerque, New Mexico, 87131
About this study
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.
- Conditions
- Cavernous Angioma, Familial, Cerebral Cavernous Malformations, Cerebral Cavernous Hemangioma
- Being tested
- Simvastatin
- Keywords
- Hispanic
- Medical subject headings
- Hemangioma, Cavernous, Central Nervous System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SimvastatinDrug
Also called Zocor
| Study group | Role | What they receive |
|---|---|---|
| Simvastatin | Experimental | 20-40 mg tablet taken daily by mouth. Month 1: 20 mg; Months 2 and 3: 40 mg. Receives: Drug: Simvastatin |
| No Treatment | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in blood brain barrier permeability over three months for the treatment group compared to the control group.
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).
Measured: Baseline, Three Months
Secondary outcomes (1)
Correlation of physiologic permeability data with anatomic lesion data
Use dynamic contrast-enhanced MRI to detect abnormalities in brain permeability in CCM patients and correlate with anatomic lesion information.
Measured: Baseline, Three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2013 (estimated)
- Study startMar 2012
- Primary completionJan 2016
- Study completionJan 2016
Why it stopped: Research was completed before January 18, 2017, \& does not meet the Applicable Clinical Trial requirement to register \& report results per the guidance provided in "Clinical Trials Registration \& Results Information Submission" dated 09/21/2016.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cavernous Angioma, FamilialStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of New Mexico
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS), University of California, San Francisco
- Responsible party
- Principal investigator, Leslie Morrison, University of New Mexico
- Investigators
- Leslie A Morrison, MD, Principal investigator, University of New MexicoBlaine Hart, MD, Principal investigator, University of New Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01764451
- Sponsor's protocol ID
- BVMC 6205
- Other IDs
- U54NS065705
- Status last verified
- Mar 2024
- First submitted
- 7 Jan 2013
- Last updated
- 12 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Permeability MRI in Cerebral Cavernous Malformations Type 1 in New Mexico: Effects of Statins
- ClinicalTrials.gov ID
- NCT01764451
- Acronym / sponsor ID
- BVMC 6205
- Conditions
- Cavernous Angioma, Familial, Cerebral Cavernous Malformations, Cerebral Cavernous Hemangioma
- Keywords
- Hispanic
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Research was completed before January 18, 2017, \& does not meet the Applicable Clinical Trial requirement to register \& report results per the guidance provided in "Clinical Trials Registration \& Results Information Submission" dated 09/21/2016.
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of New MexicoUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS), University of California, San Francisco
- Study start
- Mar 2012 (actual)
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 9 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Simvastatin | Experimental | Drug: Simvastatin20-40 mg tablet taken daily by mouth. Month 1: 20 mg; Months 2 and 3: 40 mg. |
| No Treatment | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of cerebral cavernous malformations-common Hispanic mutation (CCM1-CHM)
- Must be willing to travel to the University of New Mexico in Albuquerque, NM for 5 visits over the course of three months.
Key exclusion criteria (11 listed)
- Incarceration
- Unable to pass MRI safety screening (pregnant females, claustrophics, or those with certain metallic items implanted in their bodies)
- Low kidney function or transplants, an eGFR below 60 mL/min
- Currently taking statin medications or have taken statin medications in the past 6 months
- Known allergy or intolerance to statins
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SimvastatinAlso: Zocor | Drug | Simvastatin |
Primary outcome
Change in blood brain barrier permeability over three months for the treatment group compared to the control group.
Time frame: Baseline, Three Months
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).
1 secondary outcome
Correlation of physiologic permeability data with anatomic lesion data
Time frame: Baseline, Three months
Results and safety
The study was stopped early (reason given: Research was completed before January 18, 2017, \& does not meet the Applicable Clinical Trial requirement to register \& report results per the guidance provided in "Clinical Trials Registration \& Results Information Submission" dated 09/21/2016.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Angioma Alliance is an organization by and for those affected by cavernous angiomas and their loved ones, health professionals, and researchers.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leslie A Morrison, MD principal investigator
University of New Mexico
Blaine Hart, MD principal investigator
University of New Mexico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Simvastatin in people with Cavernous Angioma, Familial and Cerebral Cavernous Malformations, run by University of New Mexico at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Research was completed before January 18, 2017, \& does not meet the Applicable Clinical Trial requirement to register \& report results per the guidance provided in "Clinical Trials Registration \& Results Information Submission" dated 09/21/2016.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in blood brain barrier permeability over three months for the treatment group compared to the control group. (time frame: Baseline, Three Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2024.