Skip to content


The Journal of Headache and Pain

Official Journal of the "European Headache Federation" and of "Lifting The Burden - The Global Campaign against Headache"

The Journal of Headache and Pain Cover Image

Volume 16 Supplement 1

1st Joint ANIRCEF-SISC Congress

Open Access

P070. A 2-year prospective evaluation study on onabotulinumtoxinA 155 U in chronic migraine

  • Andrea Negro1Email author,
  • Lidia D'Alonzo1,
  • Noemi Lala1 and
  • Paolo Martelletti1
The Journal of Headache and Pain201516(Suppl 1):A137

Published: 28 September 2015


MigraineChronic MigraineMedication IntakePreventive DrugonabotulinumtoxinA


OnabotulinumtoxinA (Botox®) is the first and so far the only treatment to receive a specific license for prevention of chronic migraine (CM). In our Headache Clinic the therapy with onabotulinumtoxinA is routinely administered to CM patients on a daily basis since 2001. Preventive treatment with onabotulinumtoxinA was offered to all patients that were 1) adults; 2) fulfilling the ICHD-II criteria for CM with or without analgesic overuse; and 3) with contraindications or lack of efficacy or tolerability to other preventive drugs.

Exclusion criteria were coexistent neuromuscular disorders, psychiatric diseases considered incompatible with this kind of treatment, pregnancy and breast-feeding.


To prospectively evaluate the variations in terms of headache days, migraine days, acute pain medication intake days through a period of 24 months in comparison to a one-month baseline period before starting the therapy.


Among all the patients that from 2011 to 2012 underwent treatment with onabotulinumtoxinA we randomly selected 100 CM patients (F 88 / M 12; mean age 43.2, range 18-80 years; 96% drugs overusers) that were able to fill in diaries without any lack of information for a period of 2 years. OnabotulinumtoxinA 155 U was injected in 31 sites following the PREEMPT “fixed sites/fixed doses” injection paradigm every three months (± one week)[1]. Patients with criteria for medication-overuse headache underwent withdrawal and detoxification therapeutic regimen before starting the treatment. Patients were not allowed to continue preventive oral medication during treatment with onabotulinumtoxinA.


The efficacy results for each timeline are reported in Table 1. The reduction in terms of headache and migraine days, acute medication intake days and HIT-6 score increases strongly from the first injection to the fourth, and remains stable until the last injection at 24 months.
Table 1

Efficacy of onabotulinumtoxinA 155 U.



3 m

6 m

9 m

12 m

15 m

18 m

21 m

24 m

Headache days










Migraine days










Acute pain medication intake days










HIT-6 score











Our results support findings of PREEMPT study in a large cohort of patients and are representative of the patients observed in a tertiary headache centre.

Written informed consent to publish was obtained from the patient(s).

Authors’ Affiliations

Department of Clinical and Molecular Medicine, Sapienza University of Rome, Sant'Andrea Hospital, Rome, Italy


  1. Blumenfeld A, Silberstein SD, Dodick DW, Aurora SK, Turkel CC, Binder WJ: Method of injection of onabotulinumtoxinA for chronic migraine: a safe, well-tolerated, and effective treatment paradigm based on the PREEMPT clinical program. Headache. 2010, 50 (9): 1406-1418.View ArticlePubMedGoogle Scholar


© Negro et al. 2015

This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. The Creative Commons Public Domain Dedication waiver ( applies to the data made available in this article, unless otherwise stated.


By submitting a comment you agree to abide by our Terms and Community Guidelines. If you find something abusive or that does not comply with our terms or guidelines please flag it as inappropriate. Please note that comments may be removed without notice if they are flagged by another user or do not comply with our community guidelines.