Levocarnitine in Treating Patients With Vismodegib-Associated Muscle Spasms

Completed · Not applicable · Has a placebo group

Conditions studied: Musculoskeletal Complications

In brief

This randomized clinical trial studies levocarnitine in treating patients with vismodegib-associated muscle spasms. Levocarnitine may decrease muscle spasms caused by vismodegib.

Key facts

Study ID

NCT01893892

Run by

Stanford University

People needed

12

Starts

2014-03-01

Expected to finish

2017-03-15

Last updated by the study team

2017-08-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Stanford University, School of Medicine — Stanford, California, United States

Full record on ClinicalTrials.gov

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