Levocarnitine in Treating Patients With Vismodegib-Associated Muscle Spasms

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Stanford University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT01893892
First received: July 2, 2013
Last updated: May 8, 2014
Last verified: May 2014
  Purpose

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


Condition Intervention
Musculoskeletal Complications
Dietary Supplement: levocarnitine
Other: placebo
Other: questionnaire administration

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 26
Study Start Date: March 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Given PO
Other Names:
  • Carnitor
  • L-carnitine
Other: questionnaire administration
Ancillary studies
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: placebo
Given PO
Other Name: PLCB
Other: questionnaire administration
Ancillary studies

Detailed Description:

PRIMARY OBJECTIVES:

I. To determine mean number of muscle spasms per week after levocarnitine arm compared to placebo arm.

SECONDARY OBJECTIVES:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Taking vismodegib 150 mg daily at time of enrollment
  • Subject answers item #1 of muscle spasms questionnaire as moderate or severe intensity at time of screening
  • At least one muscle spasm per day at time of screening
  • Muscle spasms onset after starting vismodegib
  • Willing and able to understand and sign consent form

Exclusion Criteria:

  • Presence of muscle spasms or active neurologic disease prior to start of vismodegib
  • Use of thyroid medication at the time of screening
  • Use of Coumadin or acenocoumarol at time of screening
  • Use of muscle relaxant medications such as cyclobenzaprine within four weeks of enrollment and during course of the study
  • Presence of significant renal disease or hemodialysis which would result in dramatic reductions of systemic levocarnitine levels
  • History of seizures
  • Known deficiency in carnitine (genetic, etc.)
  • Any uncontrolled medical condition which may place the patient at increased risk during study participation (at the discretion of the clinical investigator)
  • Unable or unwilling to comply with study procedures
  • Pregnant or lactating
  • All female patients of childbearing potential including those who are within 1 year of last menstrual period will be required to take a pregnancy test during screening, enrollment and at week 0, 4, 8 and 12
  • If female of reproductive age, or male partner of female of reproductive age, unwilling to use two medically reliable forms of birth control while on vismodegib
  • Unwilling to refrain from donation of bodily fluid (blood, platelets, etc.) within 7 months of last vismodegib dose
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01893892

Locations
United States, California
Stanford University Hospitals and Clinics Recruiting
Stanford, California, United States, 94305
Contact: Anne Lynn Chang    650-721-7151    alschang@stanford.edu   
Principal Investigator: Anne Lynn Chang         
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Anne Lynn Chang Stanford University Hospitals and Clinics
  More Information

No publications provided

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT01893892     History of Changes
Other Study ID Numbers: SKIN0018, NCI-2013-01269, 27478, P30CA124435
Study First Received: July 2, 2013
Last Updated: May 8, 2014
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Spasm
Nervous System Diseases
Neurologic Manifestations
Neuromuscular Manifestations
Signs and Symptoms
Carnitine
Growth Substances
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs
Vitamin B Complex
Vitamins

ClinicalTrials.gov processed this record on October 29, 2014