Levocarnitine in Treating Patients With Vismodegib-Associated Muscle Spasms

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

Stanford is currently not accepting patients for this trial.

Stanford Investigator(s):

Intervention(s):

  • dietary supplement: levocarnitine
  • other: placebo
  • other: questionnaire administration

Eligibility


Inclusion 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

Exclusion Criteria:

   - 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

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Anne Lynn Chang
650-721-7151
Not Recruiting

Our research team includes physicians, residents, medical students, research assistants, and volunteers. Our research topics include medical imaging, device validation,  mobile application development, and pharmaceutical trials.  

Some of the Neuro-Opthalmic concerns we investigate include Multiple Sclerosis, Optic Neuritis, IIH, and ICP.