Migraine Survey in Gulf Region

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Migraine
• Intervention / Treatment: Other: erenumab

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Novartis Pharmaceuticals; Phone Number: +41613241111; Email: novartis.email@novartis.com
• Study Contact Backup: Name: Novartis Pharmaceuticals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Clinics in centers and hospitals treating adult migraine patients across the 4 Gulf Countries

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
adult migraine patients; adult migraine patients across the 4 Gulf Countries (UAE, Qatar, Oman and Kuwait)	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals
• Investigators: Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Estimated): April 30, 2024
• Primary Completion (Estimated): January 30, 2025
• Study Completion (Estimated): January 30, 2025

Study Registration Dates

• First Submitted: January 24, 2024
• First Submitted That Met QC Criteria: January 24, 2024
• First Posted (Actual): February 1, 2024

Study Record Updates

• Last Update Posted (Actual): March 27, 2024
• Last Update Submitted That Met QC Criteria: March 26, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: migraine; survey; Gulf
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Calcitonin Gene-Related Peptide Receptor Antagonists; Erenumab
• Other Study ID Numbers: CAMG334AAE02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO