Clinical trial NCT06237062: Migraine Survey in Gulf Region
Official title: Real-world Experience of Patients Newly Started on Erenumab in the Gulf Region: a Longitudinal Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Migraine
Keywords: migraine
survey
Gulf
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2024-02-01
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Clinics in centers and hospitals treating adult migraine patients across the 4 Gulf Countries

Brief 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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Mean score in the Treatment Satisfaction Questionnaire for Erenumab (TSQM) overall satisfaction scale score version 1.4
timeFrame: 12 weeks
Secondary outcomes:
measure: Mean score in TSQM version 1.4 effectiveness domain
timeFrame: Week 12
measure: Mean score in TSQM version 1.4 convenience domain
timeFrame: Week 12
measure: Mean score in TSQM version 1.4 side effects domain
timeFrame: Week 12
measure: Mean change from baseline in the score of HIT-6
timeFrame: Baseline, Week 12
measure: Mean change from baseline in the score of MIDAS at week 12
timeFrame: Baseline, Week 12
measure: Mean change from baseline in the score of WPAI
timeFrame: Baseline, Week 12
measure: Mean change from baseline in the Patients' Global Impression of Change (PGIC) scale
timeFrame: Baseline, Week 12
measure: Mean change from baseline in MMDs
timeFrame: Baseline, Week 12
measure: Mean change from baseline in MSMDs
timeFrame: Baseline, Week 12
measure: Mean change from baseline in MHDs
timeFrame: Baseline, Week 12
Other outcomes:
Locations:
city: Abu Dhabi
country: United Arab Emirates
facility: Novartis Investigative Site
city: Abu Dhabi
country: United Arab Emirates
facility: Novartis Investigative Site
city: Al Ain Abu Dhabi
country: United Arab Emirates
facility: Novartis Investigative Site
city: Dubai
country: United Arab Emirates
facility: Novartis Investigative Site
city: Ras Al Khaimah
country: United Arab Emirates
facility: Novartis Investigative Site
city: Sharjah
country: United Arab Emirates
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: