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Simvastatin for Spinal Cord Injury
Phase 2
Waitlist Available
Led By Leslie Morse, DO
Research Sponsored by Craig Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 12 months
Awards & highlights
Study Summary
This trial is testing whether simvastatin can help improve bone health in people with acute spinal cord injuries.
Eligible Conditions
- Spinal Cord Injury
- Osteoporosis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in knee bone mineral density
Secondary outcome measures
Change in bone volume
Change in community reintegration
Change in mood
+4 moreOther outcome measures
Change in bone formation
Change in bone resorption
Side effects data
From 2015 Phase 3 trial • 33 Patients • NCT0203004111%
Myalgia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Vitamin D and Placebo
Simvastatin and Placebo
Simvastatin and Vitamin D
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Simvastatin treatmentExperimental Treatment1 Intervention
Simvastatin for one year time period
Group II: Placebo treatmentPlacebo Group1 Intervention
Placebo for one year time period
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Simvastatin
2012
Completed Phase 4
~1270
Find a Location
Who is running the clinical trial?
Craig HospitalLead Sponsor
40 Previous Clinical Trials
8,283 Total Patients Enrolled
Leslie Morse, DOPrincipal Investigator - Craig Hospital
Craig Hospital
2 Previous Clinical Trials
94 Total Patients Enrolled
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