Levocarnitine in Treating Patients With Vismodegib-Associated Muscle Spasms
Trial ID or NCT#
Status
Purpose
This randomized clinical trial studies levocarnitine in treating patients with vismodegib-associated muscle spasms. Levocarnitine may decrease muscle spasms caused by vismodegib.
Official Title
Double-blind, Randomized, Placebo-controlled Two-period Crossover Study to Assess the Effect of Levocarnitine on Vismodegib-associated Muscle Spasms
Eligibility Criteria
- * 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
Investigator(s)
Contact us to find out if this trial is right for you.
Contact
Anne Lynn Chang
650-721-7151
View on ClinicalTrials.gov