Open Access

An open-label pilot study on the efficacy and tolerability of levetiracetam in the prophylaxis of migraine

  • Virgilio Gallai1Email author,
  • Andrea Alberti1,
  • Cristiana Rossi1,
  • Francesca Coppola1,
  • Beatrice Gallai1,
  • Giovanni Mazzotta1 and
  • Paola Sarchielli1
The Journal of Headache and PainOfficial Journal of the Italian Society for the Study of Headaches4:43

DOI: 10.1007/s10194-003-0043-8

Received: 13 March 2003

Accepted: 9 June 2003


A preliminary, open label study was conducted on 20 patients with migraine without aura and with high headache frequency to assess the efficacy and tolerability of the new antiepileptic drug levetiracetam. Patients were treated with levetiracetam for three months. The drug was started at a dose of 500 mg and slowly increased within 10 days to the target dose of 2000 mg/day. After 3 months of treatment, 11 (57.9%) of 19 patients who completed the study had a reduction of at least 50% in headache frequency. The intensity of migraine attacks was significantly reduced as was the use of symptomatic drugs. A 3-month carry-over effect was found in about two-thirds of the 11 patients reporting a positive treatment response. Levetiracetam was well tolerated and no patient discontinued the drug due to side effects. This preliminary study supports the potential role of levetiracetam as a new preventive treatment for migraine without aura. The promising results obtained should be confirmed by further research with a double-blind controlled design.

Key words

Levetiracetam Migraine without aura Prophylaxis Open label study