Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:44 PM
Ignite Modification Date:
2025-12-24 @ 3:44 PM
NCT ID:
NCT01893892
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01893892
Study Brief:
Protocol Section:
NCT01893892