Clinical Trial: Levocarnitine in Treating Patients With Vismodegib-Associated Muscle Spasms

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Double-blind, Randomized, Placebo-controlled Two-period Crossover Study to Assess the Effect of Levocarnitine on Vismodegib-associated Muscle Spasms

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

Detailed Summary:

PRIMARY OBJECTIVES:

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

SECONDARY OBJECTIVES:

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.


Sponsor: Stanford University

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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.


Original Secondary Outcome: Same as current

Information By: Stanford University

Dates:
Date Received: July 2, 2013
Date Started: March 2014
Date Completion: March 2017
Last Updated: October 24, 2016
Last Verified: October 2016