Migraine Survey in Gulf Region

Migraine Clinical Trial

Official title:

Real-world Experience of Patients Newly Started on Erenumab in the Gulf Region: a Longitudinal Prospective Observational Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06237062
• Other study ID #: CAMG334AAE02
• Status: Not yet recruiting
• Start date: June 30, 2024
• Est. completion date: March 30, 2025

Study information

• Verified date: May 2024
• Source: Novartis
• Contact: Novartis Pharmaceuticals
• Phone: +41613241111
• Email: novartis.email[@]novartis.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The objective of this study is to evaluate the effect of erenumab on medication-specific treatment satisfaction in patients newly started on erenumab over 12 weeks

Description:

This is a longitudinal prospective descriptive primary data collection using a 20 min online survey. Patients will be selected by investigators (general neurologists, headache/migraine specialists) in primary care clinics and hospitals. After fulfilling the inclusion criteria, the patient will be asked to sign an online informed consent. A 5 min screener will follow after which the patient will be directed through a link to the full survey. The duration of data collection will be for 6 months since the start of survey rolling in each site across centers in the Gulf Region.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: March 30, 2025
• Est. primary completion date: March 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

Other:
• erenumab
This is an observational study, there is no treatment allocation. After fulfilling the inclusion criteria and signing the informed consent, patients will be directed through a link to the full survey.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	Mean score in TSQM version 1.4 convenience 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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Mean change from baseline in MMDs	Monthly Migraine Days (MMD), describes the number of days in a month with migraine.	Baseline, Week 12
Secondary	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
Secondary	Mean change from baseline in MHDs	monthly headache days (MHD), is the number of days per month with headache.	Baseline, Week 12