Migraine Survey in Gulf Region

November 17, 2025 updated by: Novartis Pharmaceuticals

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

37

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Arab Emirates
      • Abu Dhabi, United Arab Emirates
        • Recruiting
        • Novartis Investigative Site
      • Abu Dhabi, United Arab Emirates, 112412
        • Recruiting
        • Novartis Investigative Site
      • Al Ain Abu Dhabi, United Arab Emirates
        • Recruiting
        • Novartis Investigative Site
      • Dubai, United Arab Emirates
        • Recruiting
        • Novartis Investigative Site
      • Ras Al Khaimah, United Arab Emirates
        • Recruiting
        • Novartis Investigative Site
      • Sharjah, United Arab Emirates
        • Recruiting
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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 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.

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
Time Frame: 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.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean score in TSQM version 1.4 effectiveness domain
Time Frame: 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.
Week 12
Mean score in TSQM version 1.4 convenience domain
Time Frame: 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.
Week 12
Mean score in TSQM version 1.4 side effects domain
Time Frame: 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.
Week 12
Mean change from baseline in the score of HIT-6
Time Frame: 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.
Baseline, Week 12
Mean change from baseline in the score of MIDAS at week 12
Time Frame: 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.
Baseline, Week 12
Mean change from baseline in the score of WPAI
Time Frame: 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.
Baseline, Week 12
Mean change from baseline in the Patients' Global Impression of Change (PGIC) scale
Time Frame: 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'
Baseline, Week 12
Mean change from baseline in MMDs
Time Frame: Baseline, Week 12
Monthly Migraine Days (MMD), describes the number of days in a month with migraine.
Baseline, Week 12
Mean change from baseline in MSMDs
Time Frame: Baseline, Week 12
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
Time Frame: Baseline, Week 12
monthly headache days (MHD), is the number of days per month with headache.
Baseline, Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Investigators

  • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 5, 2024

Primary Completion (Actual)

November 18, 2024

Study Completion (Actual)

November 18, 2024

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)

November 20, 2025

Last Update Submitted That Met QC Criteria

November 17, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAMG334AAE02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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