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

ConditionMigraine
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-70
SponsorFondazione Policlinico Universitario Campus Bio-Medico

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Age between 18 and 70 years-old

Chronic Migraine defined according to 1.3 ICHD-3

Informed consent

Disqualifiers

secondary headache

Onabotulinumtoxin-A in the previous 3 months

pregnancy or breastfeeding

detoxification protocol for Medication Overuse Headache in the last 6 months

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

115 Participants
are divided into 1 treatment group
Group A: Group1 (>=10years) and Group1 (<10years)1 intervention

Trial outcomes

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

Time frame
baseline to months 6 through 12

Secondary outcomes

1

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

50% or greater reduction in MMD (50% responder rate)

Time frame
from baseline to months 6 through 12 between groups
2

Number of monthly acute medications (MAM)

Change in the number of MAM

Time frame
from baseline to months 6 through 12 between groups
3

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.)

Time frame
from baseline to months 6 through 12 between groups
4

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)

Time frame
from baseline to months 6 through 12 between groups

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fondazione Policlinico Universitario Campus Bio-Medico

Lead sponsor

Source ClinicalTrials.gov
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