Musculoskeletal ComplicationsNCT01893892
Levocarnitine in Treating Patients With Vismodegib-Associated Muscle Spasms
A study testing levocarnitine and questionnaire administration in people with Musculoskeletal Complications, run by Stanford University at 1 site in United States.
Trial summary
This randomized clinical trial studies levocarnitine in treating patients with vismodegib-associated muscle spasms. Levocarnitine may decrease muscle spasms caused by vismodegib. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Musculoskeletal Complications
- What is being tested?
- levocarnitine and questionnaire administration
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to 15 Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University, School of Medicine
Stanford, California, 94305
About this study
Official title: Double-blind, Randomized, Placebo-controlled Two-period Crossover Study to Assess the Effect of Levocarnitine on Vismodegib-associated Muscle Spasms
This randomized clinical trial studies levocarnitine in treating patients with vismodegib-associated muscle spasms. Levocarnitine may decrease muscle spasms caused by vismodegib.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine the effect of levocarnitine on muscle spasm frequency compared to placebo (median percentage comparison)
SECONDARY OBJECTIVES:
- 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.
- Conditions
- Musculoskeletal Complications
- Being tested
- levocarnitine, placebo, questionnaire administration
- Keywords
- Basal Cell Carcinoma, Gorlin syndrome, Erivedge, Basal Cell Nevus Syndrome
- Medical subject headings
- Carcinoma, Basal Cell, Basal Cell Nevus Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
levocarnitineDietary supplement
Also called Carnitor, L-carnitine
Given PO
placeboOther
Also called PLCB
Given PO
questionnaire administrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: placebo; Other: questionnaire administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage difference in muscle spasm frequency (defined as number per week) between levocarnitine and placebo
Wilcoxon rank-sum test, paired
Measured: 12 weeks
Secondary outcomes (6)
Change in severity of muscle spasms after levocarnitine and placebo
Wilcoxon rank-sum test, paired
Measured: 12 weeks
Change in number of body locations affected by muscle spasms after levocarnitine and placebo
Wilcoxon rank-sum test, paired
Measured: 12 weeks
Change in impact of spasms on activities of daily living (such as sleeping or driving) after levocarnitine and placebo
as measured on questionnaire items
Measured: 12 weeks
Social/emotional impacts of muscle spasms after levocarnitine and placebo
as measured on questionnaire items
Measured: 12 weeks
Frequency of adverse events after levocarnitine and placebo
according to CTCAE 4.03
Measured: 12 weeks
Severity of adverse events after levocarnitine and placebo
according to CTCAE 4.03
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2013 (estimated)
- Study startMar 2014
- Primary completion15 Mar 2017
- Study completion15 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Musculoskeletal ComplicationsStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Anne Chang, Stanford University
- Investigators
- Anne Lynn Chang, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01893892
- Sponsor's protocol ID
- SKIN0018
- Other IDs
- NCI-2013-01269, 27478, P30CA124435
- Status last verified
- Aug 2017
- First submitted
- 2 Jul 2013
- Last updated
- 4 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind, Randomized, Placebo-controlled Two-period Crossover Study to Assess the Effect of Levocarnitine on Vismodegib-associated Muscle Spasms
- ClinicalTrials.gov ID
- NCT01893892
- Acronym / sponsor ID
- SKIN0018
- Conditions
- Musculoskeletal Complications
- Keywords
- Basal Cell Carcinoma, Gorlin syndrome, Erivedge, Basal Cell Nevus Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Mar 2014
- Primary completion
- 15 Mar 2017 (actual)
- Study completion
- 15 Mar 2017 (actual)
- First posted
- 9 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized clinical trial studies levocarnitine in treating patients with vismodegib-associated muscle spasms. Levocarnitine may decrease muscle spasms caused by vismodegib.
Detailed description
PRIMARY OBJECTIVES:
- To determine the effect of levocarnitine on muscle spasm frequency compared to placebo (median percentage comparison)
SECONDARY OBJECTIVES:
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (levocarnitine start) | Experimental | Dietary Supplement: levocarnitine, Other: questionnaire administrationPatients receive levocarnitine PO BID during weeks 1-4. Washout is weeks 5-8. Patients then cross-over to placebo for weeks 9-12. |
| Arm II (placebo start) | Placebo comparator | Other: placebo, Other: questionnaire administrationPatients receive placebo PO BID during weeks 1-4. Washout is weeks 5-8. Patients then cross-over to levocarnitine for weeks 9-12. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| levocarnitineAlso: Carnitor, L-carnitineGiven PO | Dietary supplement | Arm I (levocarnitine start) |
| placeboAlso: PLCBGiven PO | Other | Arm II (placebo start) |
| questionnaire administrationAncillary studies | Other | Arm I (levocarnitine start), Arm II (placebo start) |
Primary outcome
Percentage difference in muscle spasm frequency (defined as number per week) between levocarnitine and placebo
Time frame: 12 weeks
Wilcoxon rank-sum test, paired
6 secondary outcomes
Change in severity of muscle spasms after levocarnitine and placebo
Time frame: 12 weeks
Change in number of body locations affected by muscle spasms after levocarnitine and placebo
Time frame: 12 weeks
Change in impact of spasms on activities of daily living (such as sleeping or driving) after levocarnitine and placebo
Time frame: 12 weeks
Social/emotional impacts of muscle spasms after levocarnitine and placebo
Time frame: 12 weeks
Frequency of adverse events after levocarnitine and placebo
Time frame: 12 weeks
Severity of adverse events after levocarnitine and placebo
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne Lynn Chang principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing levocarnitine and questionnaire administration in people with Musculoskeletal Complications, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage difference in muscle spasm frequency (defined as number per week) between levocarnitine and placebo (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2017.