Ignite Creation Date:
2025-12-24 @ 3:44 PM
Ignite Modification Date:
2025-12-26 @ 11:07 AM
Study NCT ID:
NCT01893892
Status:
COMPLETED
Last Update Posted:
2017-08-04
First Post:
2013-07-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Levocarnitine in Treating Patients With Vismodegib-Associated Muscle Spasms
Sponsor:
Stanford University
Organization:
Study Overview
Official Title:
Double-blind, Randomized, Placebo-controlled Two-period Crossover Study to Assess the Effect of Levocarnitine on Vismodegib-associated Muscle Spasms
Status:
COMPLETED
Status Verified Date:
2017-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2013-01269 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| 27478 | None | None | View | |
| P30CA124435 | NIH | None | https://reporter.nih.gov/quic… | View |