Clinical trial · Interventional
Levocarnitine in Treating Patients With Vismodegib-Associated Muscle Spasms
Double-blind, Randomized, Placebo-controlled Two-period Crossover Study to Assess the Effect of Levocarnitine on Vismodegib-associated Muscle Spasms
NCT01893892CI-TRIAL-00028944completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This randomized clinical trial studies levocarnitine in treating patients with vismodegib-associated muscle spasms. Levocarnitine may decrease muscle spasms caused by vismodegib.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Musculoskeletal Complications | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| levocarnitine | Dietary Supplement | — | UNRESOLVED |
| placebo | Other | — | UNRESOLVED |
| questionnaire administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I (levocarnitine start)
- description
- Patients receive levocarnitine PO BID during weeks 1-4. Washout is weeks 5-8. Patients then cross-over to placebo for weeks 9-12.
- interventionNames
- Dietary Supplement: levocarnitine
- Other: questionnaire administration
- type
- PLACEBO_COMPARATOR
- label
- Arm II (placebo start)
- description
- Patients receive placebo PO BID during weeks 1-4. Washout is weeks 5-8. Patients then cross-over to levocarnitine for weeks 9-12.
- interventionNames
- Other: placebo
- Other: questionnaire administration
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.