MigraineNCT06237062
Migraine Survey in Gulf Region
An observational study of Migraine, run by Novartis Pharmaceuticals.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Migraine
- What is being tested?
- erenumab
- How many people
- 37 participants
- Where
- No sites listed yet
- Study dates
- 5 Jun 2024to 18 Nov 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Clinics in centers and hospitals treating adult migraine patients across the 4 Gulf Countries
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: 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
Read the 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.
- Conditions
- Migraine
- Being tested
- erenumab
- Keywords
- migraine, survey, Gulf
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
erenumabOther
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.
| Study group | Role | What they receive |
|---|---|---|
| adult migraine patients | adult migraine patients across the 4 Gulf Countries (UAE, Qatar, Oman and Kuwait) Receives: Other: erenumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (10)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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'
Measured: Baseline, Week 12
Mean change from baseline in MMDs
Monthly Migraine Days (MMD), describes the number of days in a month with migraine.
Measured: 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.
Measured: Baseline, Week 12
Mean change from baseline in MHDs
monthly headache days (MHD), is the number of days per month with headache.
Measured: Baseline, Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2024
- Study start5 Jun 2024
- Primary completion18 Nov 2024
- Study completion18 Nov 2024
Why it stopped: Company decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06237062
- Sponsor's protocol ID
- CAMG334AAE02
- Status last verified
- Nov 2025
- First submitted
- 24 Jan 2024
- Last updated
- 20 Nov 2025
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-world Experience of Patients Newly Started on Erenumab in the Gulf Region: a Longitudinal Prospective Observational Study
- ClinicalTrials.gov ID
- NCT06237062
- Acronym / sponsor ID
- CAMG334AAE02
- Conditions
- Migraine
- Keywords
- migraine, survey, Gulf
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Company decision
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 5 Jun 2024 (actual)
- Primary completion
- 18 Nov 2024 (actual)
- Study completion
- 18 Nov 2024 (actual)
- First posted
- 1 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| adult migraine patients | – | Other: erenumabadult migraine patients across the 4 Gulf Countries (UAE, Qatar, Oman and Kuwait) |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Clinics in centers and hospitals treating adult migraine patients across the 4 Gulf Countries
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| erenumabThis 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. | Other | adult migraine patients |
Primary outcome
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.
10 secondary outcomes
Mean score in TSQM version 1.4 effectiveness domain
Time frame: Week 12
Mean score in TSQM version 1.4 convenience domain
Time frame: Week 12
Mean score in TSQM version 1.4 side effects domain
Time frame: Week 12
Mean change from baseline in the score of HIT-6
Time frame: Baseline, Week 12
Mean change from baseline in the score of MIDAS at week 12
Time frame: Baseline, Week 12
Mean change from baseline in the score of WPAI
Time frame: Baseline, Week 12
Mean change from baseline in the Patients' Global Impression of Change (PGIC) scale
Time frame: Baseline, Week 12
Mean change from baseline in MMDs
Time frame: Baseline, Week 12
Mean change from baseline in MSMDs
Time frame: Baseline, Week 12
Mean change from baseline in MHDs
Time frame: Baseline, Week 12
Results and safety
The study was stopped early (reason given: Company decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
- Link to study resultsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
Questions about this trial
What is this clinical trial studying?
An observational study of Migraine, run by Novartis Pharmaceuticals.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Company decision). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean score in the Treatment Satisfaction Questionnaire for Erenumab (TSQM) overall satisfaction scale score version 1.4 (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025.