OnaBotulinumtoxin-A in Chronic Migraine Patients With Short or Long Disease History (the BACH Study)
NCT Number: NCT06537700
Acronym: BACH
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Migraine
Interventions: DRUG: OnabotulinumtoxinA OBT-A
Sponsor: Fondazione Policlinico Universitario Campus Bio-Medico
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 115
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-01-01
Completion Date: 2025-12-31
Locations: Università Studi dell'Aquila, L'Aquila, Italy|Istituto Neurologico Besta, Milano, Italy|Fondazione Policlinico Campus Bio-Medico, Roma, 00128, Italy|Policlinico Tor Vergata, Roma, Italy

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.

Primary Outcome Measures: 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 Outcome Measures: 50% or greater reduction in monthly migraine days (MMD), 50% or greater reduction in MMD (50% responder rate), from baseline to months 6 through 12 between groups|Number of monthly acute medications (MAM), Change in the number of MAM, from baseline to months 6 through 12 between groups|Pain intensity score, Numerical Rating Score NRS, Change in pain intensity score (11-point scale for self-report of pain, where 0 = no pain and 10 = extreme pain/worst possible pain.), from baseline to months 6 through 12 between groups|Pain intensity score, Present Pain Intensity PPI, Change in pain intensity score (recorded as a number from 1 to 5, in which each number is associated with the following words: 1 mild, 2 discomforting, 3 distressing, 4 horrible, 5 excruciating, i.e. higher figure means the worst outcome), from baseline to months 6 through 12 between groups|Pain quality score, the 6-point Behavioral Rating Scale (BRS-6), The BRS-6 scale describes the limitations of activities because of pain and it is articulated in 6 grades: 1. No pain, 2. Pain is present but does not limit my activities, 3. Can do most activities, 4. Unable to do some activities, 5. Unable to do most activities, 6. Unable to do any activities, from baseline to months 6 through 12 between groups|Pain quality score, the short-form McGill pain questionnaire SF-MPQ, The main component of the SF-MPQ consists of 15 pain quality descriptors (11 sensory = throbbing, shooting, stabbing, sharp, cramping, gnawing, hot-burning, aching, heavy, tender, splitting and 4 affective = tiring-exhausting, sickening, fearful and cruel-punishing) which are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate or 3 = severe, from baseline to months 6 through 12 between groups|Disability score, 6-item Headache Impact Test, Each of the six questions of the HIT-6 receives a score from 6-13. The final HIT-6 score can range from 36 to 78. A higher score indicates more disability due to headache, from baseline to months 6 through 12 between groups|Disability score, Migraine Disability Assessment MIDAS questionnaire, The MIDAS score measures disability in migraine patients every 3 months, global score minimum 0, maximum 270, higher score means worse outcome; 4 grades of disability: 0 to 5 - MIDAS Grade I, Little or no disability 6 to 10 - MIDAS Grade II, Mild disability 11 to 20 - MIDAS Grade III, Moderate disability 21+ - MIDAS Grade IV, Severe disability, from baseline to months 6 through 12 between groups|Psychological profile in terms of Trait subtest of State-Trait Anxiety Inventory (STAI), Change of STAI-Y score (Spielberger et al., 1983), a 20 multiple-choice items self-report questionnaire for measuring anxiety disorder (each item from 1=lower, 4=higher anxiety level, i.e. global score minimum 20, maximum 80, higher score means worse outcome), from baseline to months 6 through 12 between groups|Psychological profile in terms of Beck Depression Inventory-II Edition, BDI-2, Change of BDI-2 score (Beck et al., 1996), a 21 multiple-choice questions self-report inventory to measure the severity of depression (each item from 0=no symptoms, 3=higher level, the global score ranges from 0 to 63, where higher score means worse outcome), from baseline to months 6 through 12 between groups|Psychological profile in terms of Toronto Alexithymia Scale TAS-20, Change of TAS-20 score (Bressi et al., 1996) a 20 multiple-choice items self-report inventory for evaluating difficulties to identify and describe emotions (Score 20-100, where 60 or higher indicates alexithymia), from baseline to months 6 through 12 between groups