This randomized clinical trial studies levocarnitine in treating patients with vismodegib-associated muscle spasms. Levocarnitine may decrease muscle spasms caused by vismodegib.
PRIMARY OBJECTIVES: I. To determine the effect of levocarnitine on muscle spasm frequency compared to placebo (median percentage comparison) SECONDARY OBJECTIVES: I. To assess intensity of muscle spasms after levocarnitine compared to placebo. II. To assess responses related to activities of daily living or psychosocial function after levocarnitine compared to placebo. III. To assess the number of body locations affected by muscle spasms after levocarnitine or placebo. IV. To assess the frequency and severity of all adverse effects on levocarnitine versus placebo. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive levocarnitine orally (PO) twice daily (BID) during weeks 1-4. Washout is from weeks 5-8. Patients then cross-over to placebo PO twice daipy for weeks 9-12. ARM II: Patients receive placebo PO twice daily during weeks 1-4. Washout is from weeks 5-8. Patients then cross-over to levocarnitine for weeks 9-12.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
12
Stanford University, School of Medicine
Stanford, California, United States
Percentage difference in muscle spasm frequency (defined as number per week) between levocarnitine and placebo
Wilcoxon rank-sum test, paired
Time frame: 12 weeks
Change in severity of muscle spasms after levocarnitine and placebo
Wilcoxon rank-sum test, paired
Time frame: 12 weeks
Change in number of body locations affected by muscle spasms after levocarnitine and placebo
Wilcoxon rank-sum test, paired
Time frame: 12 weeks
Change in impact of spasms on activities of daily living (such as sleeping or driving) after levocarnitine and placebo
as measured on questionnaire items
Time frame: 12 weeks
Social/emotional impacts of muscle spasms after levocarnitine and placebo
as measured on questionnaire items
Time frame: 12 weeks
Frequency of adverse events after levocarnitine and placebo
according to CTCAE 4.03
Time frame: 12 weeks
Severity of adverse events after levocarnitine and placebo
according to CTCAE 4.03
Time frame: 12 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.