G43
Conditions
Interventions
Group 1: Patients with migraine are interviewed in 9 visits with 8 different questionnaires about the impact of the disease on their professional and social life as well as their quality of life. In a
Sponsors
AbbVie GmbH & Co. KG
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients able to give voluntary informed consent before starting any study related assessments or procedures (to be obtained/documented as per local regulations) 2. Male or female participants age =18 at Visit 1 3. Diagnosis of migraine for at least one year at the discretion of the study investigator according to ICHD criteria. 4. Age of the participant at the time of migraine onset < 50 years. 5. Currently taking, at the time of consent, at least one migraine medicationindicated for migraine. 6. History of=4 headache (HA) days per month on average (ICHD criteria) in the 3 month prior to screening in the investigator's judgment 7. =4 headache (HA) days in the 30-day screening period per Headache Diary
Exclusion criteria
Exclusion criteria: 1. History of migraine accompanied by diplopia or decreased level of consciousness or retinal migraine as defined by ICHD-3, 2018. 2. Current diagnosis of new persistent daily headache, hemiplegic migraine, trigeminal autonomic cephalgia (e.g., cluster headache), headache attributed to trauma or injury to the head and/or neck, headache attributed cranial and/or cervical vascular disorder, headache attributed non-vascular disorder of the cranium, neck, eyes, ears, nose, sinuses, teeth, mouth or other facial or cervical structure, or trigeminal neuralgia, or painful cranial neuropathy as defined by ICHD-3, 2018. 3. In the opinion of the investigator, participant history or current evidence of any condition that might interfere with participant's ability to comply with the study requirements
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical Outcome Variables • Change from baseline in monthly headache days every 3 Months at Months 3, 6, 9, 12, 15, 18, 21 and 24; • Change from baseline in monthly migraine days at Months 3, 6, 9, 12, 15, 18, 21 and 24; • Change from baseline in monthly acute medication use days at Months 3, 6, 9, 12, 15, 18, 21 and 24; Patient-reported Outcomes • Change from baseline in HIT-6 total score at each follow-up visit during the study; • Change from baseline in each MSQ v2.1 domain (Role Function Restrictive domain score, Role Function Preventive domain score, and Emotional Function) score at each follow-up visit; • Change from baseline in each WPAI: MIGRAINE percent subscale (Absenteeism [work time missed], Presenteeism [impairment at work/reduced on-the-job effectiveness], Work productivity loss [overall work impairment/absenteeism plus presenteeism], and Activity impairment) scores at each follow-up visit; • Change from baseline in PGI-S score at each follow-up visit; • Change from baseline in HAD-S at each follow-up visit; • Change from baseline in mTOQ-6 at each follow-up visit; • Change from baseline in MIBS-4 at each follow-up visit; • Change from baseline in MIDAS total score at each follow-up visit Migraine Treatment Pattern Characteristics • Demographics: age, gender, race, height, weight, BMI, country of residence • Baseline disease characteristics: date of initial diagnosis of migraine, migraine cohort for initial diagnosis, current medication (name, start/stop dates, dose, route, etc.) for migraine, previous medications or therapies for migraine, comorbidities associated with migraine including cardiovascular disorders (i.e., stroke, myocardial infarction), psychiatric disorders (i.e., depression, anxiety, panic disorder, bipolar disorder, personality disorders), neurologic diseases (i.e., epilepsy), sleep conditions (i.e., insomnia, sleep apnea), inflammatory conditions (i.e., asthma), and chronic pain conditions (i.e., fibromyalgia), etc. • Migraine tr | — |
Countries
Brazil, Canada, Colombia, France, Germany, Greece, Ireland, Netherlands, Portugal, Spain, Switzerland, Turkey, United Arab Emirates, United Kingdom
Contacts
Public ContactTatjana Lux
AbbVie Deutschland GmbH & Co. KG
Outcome results
None listed