Levocarnitine in Treating Patients With Vismodegib-Associated Muscle Spasms
Trial ID or NCT#
This randomized clinical trial studies levocarnitine in treating patients with vismodegib-associated muscle spasms. Levocarnitine may decrease muscle spasms caused by vismodegib.
Double-blind, Randomized, Placebo-controlled Two-period Crossover Study to Assess the Effect of Levocarnitine on Vismodegib-associated Muscle Spasms
- - 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
- - 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
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Anne Lynn Chang