Effect of Acetyl-L-carnitine in Migraine

What Was Tested

The trial (phase 4) is built around L-Carnitine for migraine.

Traditionally, beta blockers have been used for migraine prophylaxis, but in later years also antiepileptic drugs.

Contraindications and side effects have to some degree limited their use, and new prophylactics that can be used by most migraine sufferers and with little side effects are in demand.

One product that may seem to fulfill these requirements is Acetyl-L-carnitine, which is a dietary supplement and naturally occurs in plants and animals.

It had two arms (groups): Acetyl-L-carnitine (active comparator) and Sugar pills (placebo comparator).

Acetyl-L-carnitine tablets.

Glucose with lemon acid.

The registry classes the interventions as drug.

More on the Plan

The study will be a single-centre double-blinded, randomized, placebo controlled crossover study with Acetyl-L-carnitine or placebo.

The researchers plan to include 72 patients.

The follow up duration will be 36 weeks.

After a screening visit including a neurological consultation, eligible patients will sign an informed consent declaration before they enter a 4 week run-in (baseline) period when they keep a headache diary.

Who Took Part

72 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

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

Examples of who could join: Age 18 to 65 years. Signed informed consent. Migraine with or without aura according to International Classification of Headache Disorders, second version (ICHD-2) criteria. Chronic migraine according to the ICHD-2 criteria (revision 1). Retrospectively have 2 or more migraine attacks per month during the last 3 month.

The full record lists 10 inclusion and 13 exclusion criteria; among the exclusions: interval headache not distinguishable from migraine; chronic tension-type headache or other headache than migraine occurring on ≥ 15 days/month with or without medication overuse; pregnancy, nursing or inability to use contraceptives.

How the Study Was Run

The set-up was randomized, crossover and quadruple-blind.

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

Each person switched between L-Carnitine and the comparison at some point, usually with a gap in between.

As a double-blind L-Carnitine study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2013-04 with completion listed for 2014-07.

It ran at 1 site in Norway.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Headache Days (time frame: last 4 weeks).

It also tracked 1 secondary outcome, for example Days With Migraine and Side Effects.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of L-Carnitine in 72 people with migraine.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the L-Carnitine compound page, Migraine research.