NCT06237062

Brief Summary

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2024

Shorter than P25 for all trials

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 24, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 1, 2024

Completed
4 months until next milestone

Study Start

First participant enrolled

June 5, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 18, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 18, 2024

Completed
Last Updated

November 20, 2025

Status Verified

November 1, 2025

Enrollment Period

6 months

First QC Date

January 24, 2024

Last Update Submit

November 17, 2025

Conditions

Keywords

migrainesurveyGulf

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (10)

  • Mean score in TSQM version 1.4 effectiveness domain

    Week 12

  • Mean score in TSQM version 1.4 convenience domain

    Week 12

  • Mean score in TSQM version 1.4 side effects domain

    Week 12

  • Mean change from baseline in the score of HIT-6

    Baseline, Week 12

  • Mean change from baseline in the score of MIDAS at week 12

    Baseline, Week 12

  • +5 more secondary outcomes

Study Arms (1)

adult migraine patients

adult migraine patients across the 4 Gulf Countries (UAE, Qatar, Oman and Kuwait)

Other: erenumab

Interventions

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.

adult migraine patients

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Migraine Disorders

Interventions

erenumab

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 24, 2024

First Posted

February 1, 2024

Study Start

June 5, 2024

Primary Completion

November 18, 2024

Study Completion

November 18, 2024

Last Updated

November 20, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share