The Effects of L-carnitine on Fatigue in Spinal Cord Injury

What Was Tested

The trial (phase 2) is built around L-Carnitine.

The investigators expect to see an effect after approximately three weeks of treatment.

It had 1 arm (groups): L-Carnitine (experimental).

This study has a single subject design. Each subject acts as its own control. All subjects will go through intervention phase (treatment with L-Carnitine).

The registry classes the interventions as drug.

More on the Plan

This pilot study will treat 4 SCI subjects with L-Carnitine, and track the progress of their fatigue prior to, during and following treatment.

Subjects with SCI ASIA A, B or C injuries will be identified from the outpatient list of GF Strong Rehab Centre.

Subjects will be initially contacted by letter (letter attached).

In addition, recruitment posters will be posted (poster attached).

Who Took Part

The registry lists 2 actual participants took part.

It was open to people of any sex aged from 19 years up to 65 years.

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

Examples of who could join: Spinal Cord Injury: paraplegia or tetraplegia (ASIA A, B or C). More than 1 year since date of injury. Between 19 and 65 years of age. Ability to provide informed consent.

The full record lists 5 inclusion and 15 exclusion criteria; among the exclusions: spinal cord injury asia d, or lack of spinal cord injury; acute phase of rehabilitation: less than 1 year since date of injury; fatigue severity scale score less than 4.

How the Study Was Run

It was run as a randomized, single-group and open-label study.

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

Nothing was hidden in this open-label L-Carnitine study: the participants and staff both knew the treatment.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2010-10 with completion listed for 2013-04.

It ran at 1 site in Canada.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Fatigue Severity Scores (FSS) will be completed by subjects biweekly.

It also tracked 3 secondary outcomes, for example Fatigue VAS-F will be completed by subjects biweekly, Pain VAS-P will be completed by subjects biweekly and Depression CES-D will be completed by subjects biweekly.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of L-Carnitine in 2 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.