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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| adult migraine patients | adult migraine patients across the 4 Gulf Countries (UAE, Qatar, Oman and Kuwait) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| erenumab | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean score in the Treatment Satisfaction Questionnaire for Erenumab (TSQM) overall satisfaction scale score version 1.4 | 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. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Mean score in TSQM version 1.4 effectiveness domain | 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. | Week 12 |
| Mean score in TSQM version 1.4 convenience domain |
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Inclusion Criteria:
Exclusion Criteria:
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Clinics in centers and hospitals treating adult migraine patients across the 4 Gulf Countries
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
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| Label | URL |
|---|---|
| Link to study results | View source |
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| C000605816 | erenumab |
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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. |
| Week 12 |
| Mean score in TSQM version 1.4 side effects domain | 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. | Week 12 |
| Mean change from baseline in the score of HIT-6 | 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. | Baseline, Week 12 |
| Mean change from baseline in the score of MIDAS at 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. | Baseline, Week 12 |
| Mean change from baseline in the score of WPAI | 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. | Baseline, Week 12 |
| Mean change from baseline in the Patients' Global Impression of Change (PGIC) scale | 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' | Baseline, Week 12 |
| Mean change from baseline in MMDs | Monthly Migraine Days (MMD), describes the number of days in a month with migraine. | Baseline, Week 12 |
| Mean change from baseline in MSMDs | Migraine specific medication treatment days (MSMD), describes the number of days per month with the use of migraine specific treatment. | Baseline, Week 12 |
| Mean change from baseline in MHDs | monthly headache days (MHD), is the number of days per month with headache. | Baseline, Week 12 |
| D009422 | Nervous System Diseases |