Tolerability of Palmitoylethanolamide in a Pediatric Population Suffering from Migraine: A Pilot Study: Pain Research and Management

L. Papetti, G. Sforza, G. Tullo, P. Alaimo Di Loro, R. Moavero, F. Ursitti, M.A.N. Ferilli, S. Tarantino, F. Vigevano, M. Valeriani

Research output: Contribution to journalArticlepeer-review


Background. Palmitoylethanolamide (PEA) is emerging as a new therapeutic approach in pain and inflammatory conditions, and it has been evaluated in studies on various painful diseases. The aim of this open-label study was to evaluate the efficacy of ultramicronized PEA (umPEA) in the prophylactic treatment of migraine. Methods. The study included 70 patients with mean age of 10.3 ± 2.7 (24.5% M and 75.5% F). All patients had a diagnosis of migraine without aura (ICHD 3 criteria) and received umPEA (600 mg/day orally) for three months. We compared the attack frequency (AF) and attack intensity at baseline and after three months. Patients were asked to classify the intensity of the attack with a value ranging from 1 to 3, where 1 means mild attack, 2 moderate, and 3 severe attack. Results. Nine patients discontinued treatment before the target time of 12 weeks. After 3 months of treatment with umPEA, the headache frequency was reduced by >50% per month in 63.9% patients. The number of monthly attacks at T1 decreased significantly compared with the baseline assessment (from 13.9 ± 7.5 SD of T0 to 6.5 ± 5.9 SD of T1; p<0.001). The mean intensity of the attacks dropped from 1.67 ± 0.6 (T0) to 1.16 ± 0.5 (T1) (p<0.001), and the percentage of patients with severe attacks decreased after treatment (from 8.2% to 1.6%; p<0.05). The monthly assumptions of drugs for the attack reduced from 9.5 ± 4.4 to 4.9 ± 2.5 (p<0.001). Only one patient developed mild side effects (nausea and floating). Conclusions. Our preliminary data show that umPEA administered for three month reduces pain intensity and the number of attacks per month in pediatric patients with migraine. Although the small number of patients and the lack of control group do not allow us to consider these initial results as definitely reliable, they encourage us to expand the sample. © 2020 Laura Papetti et al.
Original languageEnglish
JournalPain Res. Manage.
Publication statusPublished - 2020


  • palmidrol
  • analgesic agent
  • ethanolamine derivative
  • palmitic acid derivative
  • adolescent
  • Article
  • child
  • childhood disease
  • clinical trial
  • drug efficacy
  • drug safety
  • drug tolerability
  • drug withdrawal
  • episodic migraine
  • faintness
  • female
  • human
  • major clinical study
  • male
  • migraine without aura
  • nausea
  • open study
  • pain intensity
  • particle size
  • pediatric patient
  • prospective study
  • sex difference
  • treatment duration
  • treatment response
  • migraine
  • pilot study
  • treatment outcome
  • Analgesics
  • Child
  • Ethanolamines
  • Female
  • Humans
  • Male
  • Migraine Disorders
  • Palmitic Acids
  • Pilot Projects
  • Treatment Outcome


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