RecruitingNCT06537700

OnaBotulinumtoxin-A in Chronic Migraine Patients With Short or Long Disease History (the BACH Study)

OnaBotulinumtoxin-A Effectiveness Evaluation in Chronic Migraine Patients With Short or Long Disease History: an Italian Multicentric Study (the BACH Study)


Sponsor

Fondazione Policlinico Universitario Campus Bio-Medico

Enrollment

115 participants

Start Date

Jan 1, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

The goal of this observational prospective multicentric study, 12 months duration is to investigate whether the history of Chronic Migraine and, more precisely, its duration for over or less than 10 years, can predict OBT-A treatment effectiveness. Since CM patients may have a complex psychopathological profile and psychiatric symptoms represent a bad prognostic factor influencing treatment effectiveness, the present study will also aim at evaluating if the psychopathological profile of the enrolled patients may influence the outcome.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria3

  • Age between 18 and 70 years-old
  • Chronic Migraine defined according to 1.3 ICHD-3
  • Informed consent

Exclusion Criteria4

  • secondary headache
  • Onabotulinumtoxin-A in the previous 3 months
  • pregnancy or breastfeeding
  • detoxification protocol for Medication Overuse Headache in the last 6 months

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Interventions

DRUGOnabotulinumtoxinA OBT-A

Patients will be re-evaluated every 3 months, at each OBT-A cycle, during the whole year of treatment. Every evaluation patients will show their diary of headaches with monthly migraine and headache days and acute medications taken.


Locations(6)

Università Politecnica delle Marche

Ancona, Italy

Università Studi dell'Aquila

L’Aquila, Italy

IRCCS Istituto Auxologico Italiano

Milan, Italy

Istituto Neurologico Besta

Milan, Italy

Fondazione Policlinico Campus Bio-Medico

Roma, Italy

Policlinico Tor Vergata

Roma, Italy

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NCT06537700


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