title: Acetyl-l-carnitine versus placebo for migraine prophylaxis: A randomized, triple-blind, crossover study.
abstract: 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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  EUDRACT (2012-001624-36), ClinicalTrials.gov (NCT01695317).
authors.affiliation: Department of Neuroscience, Norwegian University of Science and Technology, Norway Norwegian Advisory Unit on Headache, St. Olav's University Hospital, Norway knut.hagen@ntnu.no.
authors.forename: Knut
authors.initials: K
authors.lastname: Hagen
authors.affiliation: Department of Neuroscience, Norwegian University of Science and Technology, Norway.
authors.forename: Eiliv
authors.initials: E
authors.lastname: Brenner
authors.affiliation: Department of Neuroscience, Norwegian University of Science and Technology, Norway Norwegian Advisory Unit on Headache, St. Olav's University Hospital, Norway.
authors.forename: Mattias
authors.initials: M
authors.lastname: Linde
authors.affiliation: Norwegian Advisory Unit on Headache, St. Olav's University Hospital, Norway.
authors.forename: Gøril Bruvik
authors.initials: GB
authors.lastname: Gravdahl
authors.affiliation: Department of Neuroscience, Norwegian University of Science and Technology, Norway Norwegian Advisory Unit on Headache, St. Olav's University Hospital, Norway.
authors.forename: Erling Andreas
authors.initials: EA
authors.lastname: Tronvik
authors.affiliation: Department of Neuroscience, Norwegian University of Science and Technology, Norway Norwegian Advisory Unit on Headache, St. Olav's University Hospital, Norway.
authors.forename: Morten
authors.initials: M
authors.lastname: Engstrøm
authors.affiliation: Department of Neuroscience, Norwegian University of Science and Technology, Norway.
authors.forename: Ursula
authors.initials: U
authors.lastname: Sonnewald
authors.affiliation: Department of Neuroscience, Norwegian University of Science and Technology, Norway.
authors.forename: Grethe
authors.initials: G
authors.lastname: Helde
authors.affiliation: Department of Neuroscience, Norwegian University of Science and Technology, Norway Norwegian Advisory Unit on Headache, St. Olav's University Hospital, Norway.
authors.forename: Lars Jacob
authors.initials: LJ
authors.lastname: Stovner
authors.affiliation: Department of Neuroscience, Norwegian University of Science and Technology, Norway Norwegian Advisory Unit on Headache, St. Olav's University Hospital, Norway.
authors.forename: Trond
authors.initials: T
authors.lastname: Sand
mesh_terms: D000108:Acetylcarnitine / Q000627:therapeutic use*; D000293:Adolescent; D000328:Adult; D000368:Aged; D018592:Cross-Over Studies; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D008881:Migraine Disorders / Q000517:prevention & control*; D018697:Nootropic Agents / Q000627:therapeutic use*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D018697:Nootropic Agents; D000108:Acetylcarnitine
keywords: Migraine; crossover; placebo-controlled; single-center; triple-blind