Investigating Onabotulinumtoxin-A for Chronic Migraine Patients
OnaBotulinumtoxin-A Effectiveness Evaluation in Chronic Migraine Patients With Short or Long Disease History: an Italian Multicentric Study (the BACH Study)
This study is testing if a treatment called Onabotulinumtoxin-A can help people with chronic migraines, especially looking at how long they've had migraines and any mental health issues they might have.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 115 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Fondazione Policlinico Universitario Campus Bio-Medico Academic / other |
| Locations | 6 sites (Ancona and 5 other locations) |
| Trial ID | NCT06537700 on ClinicalTrials.gov |
What this trial studies
This observational multicentric study aims to evaluate the effectiveness of Onabotulinumtoxin-A (OBT-A) in treating Chronic Migraine (CM) patients based on the duration of their condition, specifically comparing those with a history of less than 10 years to those with more. The study will also assess how psychiatric comorbidities may influence treatment outcomes. Conducted over 12 months, it will involve patients from various Italian tertiary headache centers. The findings could help identify the best candidates for OBT-A treatment and optimize its use in clinical practice.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 70 with a diagnosis of Chronic Migraine.
Not a fit: Patients with secondary headaches, recent OBT-A treatment, or those who are pregnant or breastfeeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for Chronic Migraine patients, enhancing their quality of life.
How similar studies have performed: Previous studies have shown effectiveness of OBT-A in reducing migraine frequency, but this specific approach of correlating treatment effectiveness with disease duration and psychiatric profiles is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age between 18 and 70 years-old * Chronic Migraine defined according to 1.3 ICHD-3 * Informed consent Exclusion Criteria: * secondary headache * Onabotulinumtoxin-A in the previous 3 months * pregnancy or breastfeeding * detoxification protocol for Medication Overuse Headache in the last 6 months
Where this trial is running
Ancona and 5 other locations
- 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, Italy (Recruiting)
- Policlinico Tor Vergata — Roma, Italy (Recruiting)
Study contacts
- Study coordinator: Fabrizio Vernieri, Prof.
- Email: f.vernieri@policlinicocampus.it
- Phone: 003906225411889
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.