NCT01893892

Levocarnitine in Treating Patients With Vismodegib-Associated Muscle Spasms

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Musculoskeletal Complications

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	levocarnitine	Given PO
OTHER	placebo	Given PO
OTHER	questionnaire administration	Ancillary studies

Timeline

• Start date: 2014-03-01
• Primary completion: 2017-03-15
• Completion: 2017-03-15
• First posted: 2013-07-09
• Last updated: 2017-08-04

Locations

1 site across 1 country: United States