Status:
COMPLETED
Levocarnitine in Treating Patients With Vismodegib-Associated Muscle Spasms
Lead Sponsor:
Stanford University
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Musculoskeletal Complications
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This randomized clinical trial studies levocarnitine in treating patients with vismodegib-associated muscle spasms. Levocarnitine may decrease muscle spasms caused by vismodegib.
Detailed Description
PRIMARY OBJECTIVES: I. To determine the effect of levocarnitine on muscle spasm frequency compared to placebo (median percentage comparison) SECONDARY OBJECTIVES: I. To assess intensity of muscle s...
Eligibility Criteria
Inclusion
- Taking vismodegib daily
- Subject answers item #1 of muscle spasms questionnaire as moderate or severe intensity at time of screening
- At least one muscle spasm per day at time of screening
- Muscle spasms onset after starting vismodegib
- Willing and able to understand and sign consent form
Exclusion
- Presence of muscle spasms or active neurologic disease prior to start of vismodegib
- Use of thyroid medication at the time of screening
- Use of Coumadin or acenocoumarol at time of screening
- Change in regimen of muscle relaxant medications within four weeks of enrollment
- If on stable muscle relaxant medication regimen for 4 weeks prior to enrolling, not willing to maintain muscle relaxant regimen without change during course of the study
- Presence of significant renal disease or hemodialysis which would result in dramatic reductions of systemic levocarnitine levels
- History of seizures
- Known deficiency in carnitine (genetic, etc.)
- Any uncontrolled medical condition which may place the patient at increased risk during study participation (at the discretion of the clinical investigator)
- Unable or unwilling to comply with study procedures
- Pregnant or lactating
- All female patients of childbearing potential including those who are within 1 year of last menstrual period will be required to take a pregnancy test during screening, enrollment and at week 0, 4, 8 and 12
- If female of reproductive age, or male partner of female of reproductive age, unwilling to use two medically reliable forms of birth control while on vismodegib
- Unwilling to refrain from donation of bodily fluid (blood, platelets, etc.) within 7 months of last vismodegib dose
Key Trial Info
Start Date :
March 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 15 2017
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT01893892
Start Date
March 1 2014
End Date
March 15 2017
Last Update
August 4 2017
Active Locations (1)
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1
Stanford University, School of Medicine
Stanford, California, United States, 94305