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

Status: Recruiting
Location: See all (6) locations...
Intervention Type: Drug
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• Age between 18 and 70 years-old

• Chronic Migraine defined according to 1.3 ICHD-3

• Informed consent

Locations
Other Locations
Italy
Università Politecnica delle Marche
RECRUITING
Ancona
Università Studi dell'Aquila
RECRUITING
L’aquila
IRCCS Istituto Auxologico Italiano
RECRUITING
Milan
Istituto Neurologico Besta
RECRUITING
Milan
Fondazione Policlinico Campus Bio-Medico
RECRUITING
Roma
Policlinico Tor Vergata
RECRUITING
Roma
Contact Information
Primary
Fabrizio Vernieri, Prof.
f.vernieri@policlinicocampus.it
003906225411889
Backup
Claudia Altamura, MD
c.altamura@policlinicocampus.it
003906225411270
Time Frame
Start Date: 2024-01-01
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 115
Treatments
Group1 (>=10years) and Group1 (<10years)
Patients will be divided into 2 groups according to their CM history (duration): A) those from 1 to 9 years and B) those with 10 or more years of CM history.
Related Therapeutic Areas
Sponsors
Leads: Fondazione Policlinico Universitario Campus Bio-Medico

This content was sourced from clinicaltrials.gov