Levocarnitine in Treating Patients With Vismodegib-Associated Muscle Spasms

Musculoskeletal Complications Clinical Trial

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

Status Completed

Clinical Trial Summary

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

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Musculoskeletal Complications
• Spasm

• NCT number: NCT01893892
• Study type: Interventional
• Source: Stanford University
• Status: Completed
• Phase: N/A
• Start date: March 2014
• Completion date: March 15, 2017