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Levocarnitine in Treating Patients With Vismodegib-Associated Muscle Spasms

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Anne Chang, Stanford University
ClinicalTrials.gov Identifier:
NCT01893892
First received: July 2, 2013
Last updated: August 3, 2017
Last verified: August 2017
  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
Intervention Model: Crossover Assignment
Masking: Double (Participant, 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 Anne Chang, Stanford University:

Primary Outcome Measures:
  • Percentage difference in muscle spasm frequency (defined as number per week) between levocarnitine and placebo [ Time Frame: 12 weeks ]
    Wilcoxon rank-sum test, paired


Secondary Outcome Measures:
  • Change in severity of muscle spasms after levocarnitine and placebo [ Time Frame: 12 weeks ]
    Wilcoxon rank-sum test, paired

  • Change in number of body locations affected by muscle spasms after levocarnitine and placebo [ Time Frame: 12 weeks ]
    Wilcoxon rank-sum test, paired

  • Change in impact of spasms on activities of daily living (such as sleeping or driving) after levocarnitine and placebo [ Time Frame: 12 weeks ]
    as measured on questionnaire items

  • Social/emotional impacts of muscle spasms after levocarnitine and placebo [ Time Frame: 12 weeks ]
    as measured on questionnaire items

  • Frequency of adverse events after levocarnitine and placebo [ Time Frame: 12 weeks ]
    according to CTCAE 4.03

  • Severity of adverse events after levocarnitine and placebo [ Time Frame: 12 weeks ]
    according to CTCAE 4.03


Enrollment: 12
Study Start Date: March 2014
Study Completion Date: March 15, 2017
Primary Completion Date: March 15, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I (levocarnitine start)
Patients receive levocarnitine PO BID during weeks 1-4. Washout is weeks 5-8. Patients then cross-over to placebo for weeks 9-12.
Dietary Supplement: levocarnitine
Given PO
Other Names:
  • Carnitor
  • L-carnitine
Other: questionnaire administration
Ancillary studies
Placebo Comparator: Arm II (placebo start)
Patients receive placebo PO BID during weeks 1-4. Washout is weeks 5-8. Patients then cross-over to levocarnitine for weeks 9-12.
Other: placebo
Given PO
Other Name: PLCB
Other: questionnaire administration
Ancillary studies

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Taking vismodegib daily
  • 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
  • Change in regimen of muscle relaxant medications within four weeks of enrollment
  • If on stable muscle relaxant medication regimen for 4 weeks prior to enrolling, not willing to maintain muscle relaxant regimen without change 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, School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
National Cancer Institute (NCI)
Investigators
Principal Investigator: Anne Lynn Chang Stanford University
  More Information

Responsible Party: Anne Chang, Associate Professor of Dermatology, Stanford University
ClinicalTrials.gov Identifier: NCT01893892     History of Changes
Other Study ID Numbers: SKIN0018
NCI-2013-01269 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
27478
P30CA124435 ( U.S. NIH Grant/Contract )
Study First Received: July 2, 2013
Last Updated: August 3, 2017

Keywords provided by Anne Chang, Stanford University:
Basal Cell Carcinoma
Gorlin syndrome
Erivedge
Basal Cell Nevus Syndrome

Additional relevant MeSH terms:
Spasm
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on September 20, 2017