Acetyl-l-carnitine versus placebo for migraine prophylaxis: A randomized, triple-blind, crossover study

Cephalalgia. 2015 Oct;35(11):987-95. doi: 10.1177/0333102414566817. Epub 2015 Jan 19.


Background: Preventive medication is indicated for many migraine patients, but is used in relatively few. The aim of the present study was to evaluate the efficacy of acetyl-l-carnitine as a prophylactic drug in migraine patients.

Methods: A single-center, randomized, triple-blind, placebo-controlled, crossover study was carried out. Men and women, age 18-65 years, with episodic migraine but otherwise healthy, were recruited mostly through advertisements. After a four-week run-in-phase, 72 participants were randomized to receive either placebo or 3 g acetyl-l-carnitine for 12 weeks. After a four-week washout, treatment was switched. The primary outcome was days with moderate or severe headache per four weeks. Secondary outcomes were days with headache, hours with headache, proportion of responders (>50% reduction in migraine days from baseline) and adverse events.

Results: In the complete case analyses, no statistically significant differences were found between acetyl-l-carnitine and placebo in severe or moderate headache days per month (3.0 versus 3.1, p = 0.80), headache days per month (5.1 versus 5.2, p = 0.73) or for the other secondary outcome measures.

Conclusion: In this triple-blind crossover study no differences were found in headache outcomes between acetyl-l-carnitine and placebo. Our results do not provide evidence of benefit for efficacy of acetyl-l-carnitine as prophylactic treatment for migraine.

Trial registration: EUDRACT (2012-001624-36), (NCT01695317).

Keywords: Migraine; crossover; placebo-controlled; single-center; triple-blind.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Acetylcarnitine / therapeutic use*
  • Adolescent
  • Adult
  • Aged
  • Cross-Over Studies
  • Female
  • Humans
  • Male
  • Middle Aged
  • Migraine Disorders / prevention & control*
  • Nootropic Agents / therapeutic use*
  • Treatment Outcome
  • Young Adult


  • Nootropic Agents
  • Acetylcarnitine

Associated data

  • EudraCT/2012-001624-36