Levocarnitine in Treating Patients With Vismodegib-Associated Muscle Spasms

NCT01893892 | Completed DMC

• 4 other identifiers: SKIN0018NCI-2013-0126927478P30CA124435
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Musculoskeletal Complications

Keywords

Basal Cell Carcinoma; Gorlin syndrome; Erivedge; Basal Cell Nevus Syndrome

Outcome Measures

Primary Outcomes (1)

• Percentage difference in muscle spasm frequency (defined as number per week) between levocarnitine and placebo

  Wilcoxon rank-sum test, paired

  12 weeks

Secondary Outcomes (6)

• Change in severity of muscle spasms after levocarnitine and placebo

  12 weeks

• Change in number of body locations affected by muscle spasms after levocarnitine and placebo

  12 weeks

• Change in impact of spasms on activities of daily living (such as sleeping or driving) after levocarnitine and placebo

  12 weeks

• Social/emotional impacts of muscle spasms after levocarnitine and placebo

  12 weeks

• Frequency of adverse events after levocarnitine and placebo

  12 weeks

Study Arms (2)

Arm I (levocarnitine start)

EXPERIMENTAL

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; Other: questionnaire administration

Arm II (placebo start)

PLACEBO COMPARATOR

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; Other: questionnaire administration

Interventions

levocarnitine DIETARY_SUPPLEMENT

Given PO

Also known as: Carnitor, L-carnitine

Arm I (levocarnitine start)

placebo OTHER

Given PO

Also known as: PLCB

Arm II (placebo start)

questionnaire administration OTHER

Ancillary studies

Arm I (levocarnitine start); Arm II (placebo start)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Stanford University, School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Carcinoma, Basal Cell; Basal Cell Nevus Syndrome

Interventions

Carnitine

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Basal Cell; Odontogenic Cysts; Jaw Cysts; Bone Cysts; Cysts; Neoplastic Syndromes, Hereditary; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Jaw Diseases; Stomatognathic Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn

Intervention Hierarchy (Ancestors)

Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals

Study Officials

• Anne Lynn Chang

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Dermatology

Study Record Dates

• First Submitted: July 2, 2013
• First Posted: July 9, 2013
• Study Start: March 1, 2014
• Primary Completion: March 15, 2017
• Study Completion: March 15, 2017
• Last Updated: August 4, 2017

Record last verified: 2017-08

Locations

US (1)