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

NCT06537700 | Recruiting

• 2 other identifiers: 001.23(02.23) OSSFondazione PCBM
• Study Type: observational
• Target: 115
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

Migraine

Keywords

Chronic migraine; OnabotulinumtoxinA; Migraine prevention; Disease duration; Psychiatric comorbidities

Outcome Measures

Primary Outcomes (1)

• Monthly Migraine Days (MMD), Monthly Headache Days (MHD)

  Change in the mean number of MMD (and MHD) from baseline to months 6 through 12 between groups

  baseline to months 6 through 12

Secondary Outcomes (11)

• 50% or greater reduction in monthly migraine days (MMD)

  from baseline to months 6 through 12 between groups

• Number of monthly acute medications (MAM)

  from baseline to months 6 through 12 between groups

• Pain intensity score, Numerical Rating Score NRS

  from baseline to months 6 through 12 between groups

• Pain intensity score, Present Pain Intensity PPI

  from baseline to months 6 through 12 between groups

• Pain quality score, the 6-point Behavioral Rating Scale (BRS-6)

  from baseline to months 6 through 12 between groups

Study Arms (1)

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.

Drug: OnabotulinumtoxinA OBT-A

Interventions

OnabotulinumtoxinA OBT-A DRUG

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.

Group1 (>=10years) and Group1 (<10years)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consecutive CM patients (according to ICHD-3 1.3) treated in 8 Italian headache centers, undergoing OBT-A, will be enrolled.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Fondazione Policlinico Universitario Campus Bio-Medico: lead

Study Sites (6)

Università Politecnica delle Marche

Ancona, Italy

RECRUITING

Università Studi dell'Aquila

L’Aquila, Italy

RECRUITING

IRCCS Istituto Auxologico Italiano

Milan, Italy

RECRUITING

Istituto Neurologico Besta

Milan, Italy

RECRUITING

Fondazione Policlinico Campus Bio-Medico

Roma, 00128, Italy

RECRUITING

Policlinico Tor Vergata

Roma, Italy

RECRUITING

Related Publications (1)

• Vernieri F, Paolucci M, Altamura C, Pasqualetti P, Mastrangelo V, Pierangeli G, Cevoli S, D'Amico D, Grazzi L. Onabotulinumtoxin-A in Chronic Migraine: Should Timing and Definition of Non-Responder Status Be Revised? Suggestions From a Real-Life Italian Multicenter Experience. Headache. 2019 Sep;59(8):1300-1309. doi: 10.1111/head.13617. Epub 2019 Aug 27.

  PMID: 31454075 BACKGROUND

Related Links

• link to reference

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Fabrizio Vernieri, Prof.

CONTACT

003906225411889; f.vernieri@policlinicocampus.it

Claudia Altamura, MD

CONTACT

003906225411270; c.altamura@policlinicocampus.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2024
• First Posted: August 5, 2024
• Study Start: January 1, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-06

Locations

IT (6)