Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 3:44 PM
Ignite Modification Date:
2025-12-24 @ 3:44 PM
NCT ID:
NCT01893892
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 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.
Study:
NCT01893892
Study Brief:
Protocol Section:
NCT01893892