Levocarnitine in Treating Patients With Vismodegib-Associated Muscle Spasms
Dietary Supplement: levocarnitine
Other: questionnaire administration
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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|
- Mean difference in muscle spasm number in a week [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: No ]Wilcoxon rank-sum test will be used for analysis, with and without adjustment for co-variates including as age, gender and duration on vismodegib.
- Mean severity of muscle spasm [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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.
|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)|
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
Other Names:Other: questionnaire administration
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 Name: PLCBOther: questionnaire administration
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01893892
|United States, California|
|Stanford University, School of Medicine|
|Stanford, California, United States, 94305|
|Principal Investigator:||Anne Lynn Chang||Stanford University|