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Levocarnitine in Treating Patients With Vismodegib-Associated Muscle Spasms

This study is ongoing, but not recruiting participants.
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Stanford University Identifier:
First received: July 2, 2013
Last updated: October 24, 2016
Last verified: October 2016
This randomized clinical trial studies levocarnitine in treating patients with vismodegib-associated muscle spasms. Levocarnitine may decrease muscle spasms caused by vismodegib.

Condition Intervention
Musculoskeletal Complications
Dietary Supplement: levocarnitine
Other: placebo
Other: questionnaire administration

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: Double-blind, Randomized, Placebo-controlled Two-period Crossover Study to Assess the Effect of Levocarnitine on Vismodegib-associated Muscle Spasms

Resource links provided by NLM:

Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Mean difference in muscle spasm number in a week [ Time Frame: Up to 12 weeks ]
    Wilcoxon rank-sum test will be used for analysis, with and without adjustment for co-variates including as age, gender and duration on vismodegib.

Secondary Outcome Measures:
  • Mean severity of muscle spasm [ Time Frame: Up to 12 weeks ]
    Wilcoxon rank-sum test will be used for analysis for treatment difference. Covariates will be used for adjustment via the Cochran-Mantel-Haenszel general association statistic, including age, gender and duration of vismodegib.

  • Proportion of participants who answered "yes" to functional and psychosocial effects of muscle spasms [ Time Frame: Up to 12 weeks ]
    Each item will be analyzed separately from each other. Subjective responses to questionnaire items such as location on the body of muscle spasms or character of the muscle spasms will be reported in descriptive terms in the final report. Effect of muscle spasms on activities of daily living and psychosocial impact will be recorded and checked by the subject will be compared between the levocarnitine and placebo arms by Cochran-Mantel-Haenszel analysis of variance (ANOVA) statistic to adjust for covariate effects of age, gender, and duration on vismodegib.

Enrollment: 11
Study Start Date: March 2014
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I (levocarnitine)
Patients receive levocarnitine PO every 6 hours BID during weeks 1-4. Patients then cross-over to Arm II for weeks 8-12.
Dietary Supplement: levocarnitine
Given PO
Other Names:
  • Carnitor
  • L-carnitine
Other: questionnaire administration
Ancillary studies
Placebo Comparator: Arm II (placebo)
Patients receive placebo PO every 6 hours BID during weeks 1-4. Patients then cross-over to Arm I for weeks 8-12.
Other: placebo
Given PO
Other Name: PLCB
Other: questionnaire administration
Ancillary studies

Detailed Description:


I. To determine mean number of muscle spasms per week after levocarnitine arm compared to placebo arm.


I. To assess intensity of muscle spasms per week after levocarnitine arm compared to placebo arm.

II. To assess responses related to activities of daily living or psychosocial function after 4 weeks of placebo or 4 weeks of levocarnitine.

III. To assess the frequency 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) every 6 hours twice daily (BID) during weeks 1-4. Patients then cross-over to Arm II for weeks 8-12.

ARM II: Patients receive placebo PO every 6 hours BID during weeks 1-4. Patients then cross-over to Arm I for weeks 8-12.

After completion of study, patients are followed up at 4 weeks.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  • Use of muscle relaxant medications such as cyclobenzaprine within four weeks of enrollment and 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
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Please refer to this study by its identifier: NCT01893892

United States, California
Stanford University, School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
National Cancer Institute (NCI)
Principal Investigator: Anne Lynn Chang Stanford University
  More Information

Responsible Party: Stanford University Identifier: NCT01893892     History of Changes
Other Study ID Numbers: SKIN0018
NCI-2013-01269 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
P30CA124435 ( US NIH Grant/Contract Award Number )
Study First Received: July 2, 2013
Last Updated: October 24, 2016

Keywords provided by Stanford University:
Basal Cell Carcinoma
Gorlin syndrome
Basal Cell Nevus Syndrome

Additional relevant MeSH terms:
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms processed this record on May 22, 2017