Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
76 participants
INTERVENTIONAL
2017-07-01
2023-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Simvastatin treatment
Simvastatin for one year time period
Simvastatin
12 month course of daily simvastatin
Placebo treatment
Placebo for one year time period
Placebo Oral Capsule
12 month course of daily placebo
Interventions
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Placebo Oral Capsule
12 month course of daily placebo
Simvastatin
12 month course of daily simvastatin
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* acute SCI (AIS A-C) who are enrolled at our center in an ongoing surveillance study.
* use a wheelchair as their primary mobility mode
* reside in the greater Denver metropolitan area
* within 3 months of injury
* medically stable
* able to follow directions
* provide informed consent.
Exclusion Criteria
* drug allergy,
* active liver disease,
* renal dysfunction,
* concurrent use of drugs that cause myopathy or increase the risk of myopathy with simvastatin therapy (gemfibrozil, niacin, cyclosporine, danazol, amiodarone, dronedarone, ranolazine, calcium channel blockers, colchicine), strong CYP34A inhibitors (itraconazole, ketoconazole, posaconazole, voriconazole, erythromycin, clarithromycin, telithromycin, HIV protease inhibitors, boceprevir, telaprevir, nefazodone, cobicistat-containing products), low plasma cholesterol levels,
* uncontrolled or poorly controlled diabetes,
* unstable anti-coagulation treatment,
* taking a statin in the preceding 12 months,
* metabolic bone disease, thyroid disorder,
* history of bilateral oophorectomy,
* current use of medications potentially affecting bone health including bisphosphonates, androgenic steroids, estrogenic steroids, anti-epileptics, lithium glucocorticoid use for more than 3 months,
* have received inhaled glucocorticoids in the past 12 months,
* pregnant or lactating women,
* women of childbearing potential who are unwilling or unable to use a reliable form of contraception.
18 Years
60 Years
ALL
No
Sponsors
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Craig Hospital
OTHER
Responsible Party
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Leslie Morse
Principal Investigator
Principal Investigators
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Leslie Morse, DO
Role: PRINCIPAL_INVESTIGATOR
Craig Hospital
Locations
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Craig Hospital
Englewood, Colorado, United States
Countries
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References
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Kowalski JL, Nguyen N, Battaglino RA, Falci SP, Charlifue S, Morse LR. miR-338-5p Levels and Cigarette Smoking are Associated With Neuropathic Pain Severity in Individuals With Spinal Cord Injury: Preliminary Findings From a Genome-Wide microRNA Expression Profiling Screen. Arch Phys Med Rehabil. 2022 Apr;103(4):738-746. doi: 10.1016/j.apmr.2021.09.005. Epub 2021 Oct 27.
Other Identifiers
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SCIMS Statin
Identifier Type: -
Identifier Source: org_study_id