Levocarnitine in Treating Patients With Vismodegib-Associated Muscle Spasms

What Was Tested

This registered not phased trial tested L-Carnitine.

This randomized clinical trial studies levocarnitine in treating patients with vismodegib-associated muscle spasms.

It had two arms (groups): Arm I (levocarnitine start) (experimental) and Arm II (placebo start) (placebo comparator).

Patients receive levocarnitine PO BID during weeks 1-4. Washout is weeks 5-8. Patients then cross-over to placebo for weeks 9-12.

Patients receive placebo PO BID during weeks 1-4. Washout is weeks 5-8. Patients then cross-over to levocarnitine for weeks 9-12.

The registry classes the interventions as dietary supplement and other.

More on the Plan

To assess intensity of muscle spasms after levocarnitine compared to placebo.

To assess responses related to activities of daily living or psychosocial function after levocarnitine compared to placebo.

To assess the number of body locations affected by muscle spasms after levocarnitine or placebo.

To assess the frequency and severity of all adverse effects on levocarnitine versus placebo.

Who Took Part

Enrollment: 12 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could 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.

The full record lists 5 inclusion and 14 exclusion criteria; among the exclusions: 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.

How the Study Was Run

Design: randomized, crossover and double-blind.

The participants were allocated by chance, so the L-Carnitine group and the comparison group should start out alike.

In the crossover set-up each of the participants took both L-Carnitine and the comparison in turn, acting as their own control.

Neither the participants nor the staff measuring them knew who was on L-Carnitine, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and investigator.

It started in 2014-03 with completion listed for 2017-03-15.

It ran at 1 site in United States.

Its stated primary purpose is supportive care.

What Was Measured

Primary outcome: Percentage difference in muscle spasm frequency (defined as number per week) between levocarnitine and placebo (time frame: 12 weeks).

It also tracked 6 secondary outcomes, for example Change in severity of muscle spasms after levocarnitine and placebo, Change in number of body locations affected by muscle spasms after levocarnitine and placebo, Change in impact of spasms on activities of daily living (such as sleeping or driving) after levocarnitine and placebo, Social/emotional impacts of muscle spasms after levocarnitine and placebo, Frequency of adverse events after levocarnitine and placebo and Severity of adverse events after levocarnitine and placebo.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of L-Carnitine in 12 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the L-Carnitine compound page, all human trials.