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Not Recruiting
Trial ID: NCT01893892
Double-blind, Randomized, Placebo-controlled Two-period Crossover Study to Assess the Effect of Levocarnitine on Vismodegib-associated Muscle Spasms
Eugene and Gloria Bauer Professor
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
dietary supplement: levocarnitine
other: placebo
other: questionnaire administration
Not Recruiting
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Anne Lynn Chang
650-721-7151