Migraine
Conditions
Keywords
migraine, survey, Gulf
Brief summary
The objective of this study was to evaluate the effect of erenumab on medication-specific treatment satisfaction in patients who newly started on erenumab over 12 weeks
Detailed description
This was a longitudinal prospective descriptive primary data collection using a 20 min online survey. Patients were selected by investigators (general neurologists, headache/migraine specialists) in primary care clinics and hospitals. After fulfilling the inclusion criteria, the patient were asked to sign an online informed consent. A 5 min screener followed after which the patient was directed through a link to the full survey. The duration of data collection was for 6 months since the start of survey rolling in each site across centers in the Gulf Region.
Interventions
OTHERerenumab
This was an observational study, there was no treatment allocation. After fulfilling the inclusion criteria and signing the informed consent, patients were directed through a link to the full survey.
Sponsors
Novartis Pharmaceuticals
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* EM& CM (with or without Medication Overuse Headache (MOH)) patients * Newly Started on erenumab either 70 mg or 140 mg (first dose received within 1 month prior study enrollment and baseline endpoints collection) * Ability to receive 3 monthly doses of erenumab. * Age more than 18 years * Males and Females * Allowing the patients to be stable on 1 adjunctive migraine preventive medication (if present) * Agreed to be included in the study and signed informed consent
Exclusion criteria
* Less than 18 years * Age at onset of Migraine more than 50 years * Any contraindications to the start of erenumab as per label * Refusal to sign informed consent * Inability to participate or restricted access to the online survey * Enrolled in an interventional migraine-related study at the time of the study enrollement
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean score in the Treatment Satisfaction Questionnaire for Erenumab (TSQM) overall satisfaction scale score version 1.4 | 12 weeks | TSQM is used to measure the Patients' self-reported satisfaction or dissatisfaction with the study treatment. The TSQM version 1.4 domain scores range from 0 to 100 with higher scores representing a higher satisfaction on that domain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean score in TSQM version 1.4 convenience domain | Week 12 | TSQM is used to measure the Patients' self-reported satisfaction or dissatisfaction with the study treatment. The TSQM version 1.4 domain scores range from 0 to 100 with higher scores representing a higher satisfaction on that domain. |
| Mean score in TSQM version 1.4 side effects domain | Week 12 | TSQM is used to measure the Patients' self-reported satisfaction or dissatisfaction with the study treatment. The TSQM version 1.4 domain scores range from 0 to 100 with higher scores representing a higher satisfaction on that domain. |
| Mean change from baseline in the score of HIT-6 | Baseline, Week 12 | Headache Impact Test (HIT-6) is a short-form self-administered questionnaire based on the internet-HIT question pool. The HIT-6 was developed as a global measure of adverse headache impact to assess headache severity in the previous month and change in a patient's clinical status over a short period of time. Six items assess the frequency of pain severity, headaches limiting daily activity (household, work, school, and social). Each of the 6 questions is responded to using 1 of 5 response categories: never, rarely, sometimes, very often, or always. The total HIT-6 score ranges from 36 to 78. Lower values represent better outcomes, therefore negative change denotes improvement. |
| Mean change from baseline in the score of MIDAS at week 12 | Baseline, Week 12 | Migraine Disability Assessment (MIDAS) Questionnaire was developed to assess headache-related disability with the aim of improving migraine care. Headache sufferers answer five questions, scoring the number of days, in the past 3 months of activity limitations due to migraine. The total MIDAS score is the sum of the days given as response to these five questions (MIDAS 1 to MIDAS 5). The total score ranges from 0 to 90 and is used to categorize patients in disability grades I to IV. A higher score means more severe disability, placing the patient in a higher disability grade. |
| Mean score in TSQM version 1.4 effectiveness domain | Week 12 | TSQM is used to measure the Patients' self-reported satisfaction or dissatisfaction with the study treatment. The TSQM version 1.4 domain scores range from 0 to 100 with higher scores representing a higher satisfaction on that domain. |
| Mean change from baseline in the Patients' Global Impression of Change (PGIC) scale | Baseline, Week 12 | The PGIC evaluates overall health status as perceived by the patient in a seven-point single-item scale ranging from 'very much worse' to 'very much improved' |
| Mean change from baseline in MMDs | Baseline, Week 12 | Monthly Migraine Days (MMD), describes the number of days in a month with migraine. |
| Mean change from baseline in MSMDs | Baseline, Week 12 | Migraine specific medication treatment days (MSMD), describes the number of days per month with the use of migraine specific treatment. |
| Mean change from baseline in MHDs | Baseline, Week 12 | monthly headache days (MHD), is the number of days per month with headache. |
| Mean change from baseline in the score of WPAI | Baseline, Week 12 | The Work Productivity Activity Impairment (WPAI) questionnaire measures the amount of absence or presence for work attendance and daily work activity impairment. A higher score on the WPAI indicates greater impairment and loss of productivity. |
Outcome results
None listed