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MigraineEVIREMIGNCT05947123

Real-life Study of the Efficacy of Management of Migraine Patients After Failure of 2 Prophylactic Treatments

An observational study of Migraine, run by Centre Hospitalier Régional Metz-Thionville at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a real-life, observational, single-center cohort study to describe the efficacy of prophylactic treatment in patients after failure of at least 2 prophylactic treatments. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Migraine
What is being tested?
Patient health care observational follow up after 2 prophylactic tratments
How many people
127 participants
Where
1 siteFrance
Study dates
1 Jun 2023to 1 Mar 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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with Migraine [International Headache Society (IHS) criteria 2013, revised 2018] with or without aura

Who may be able to join

  • Patients with Migraine [International Headache Society (IHS) criteria 2013, revised 2018] with or without aura
  • Monthly number of attacks ≥ 8 for at least 3 months
  • Indication for prophylactic treatment
  • For eptinezumab: resistance to at least 2 conventional disease-modifying therapies
  • Agrees to use data for research purposes

Who cannot join

  • Vascular history: myocardial infarction (MI), unstable angina or coronary bypass surgery, stroke or transient ischemic attack (TIA), Peripheral Arterial Disease of the Lower Limbs (PAD), uncontrolled hypertension
  • Need for analgesics for a cause other than migraine
  • Difficulty in understanding French language or cognitive impairment that compromises completion of self-questionnaires.

Trial locations and contacts

1 site in 1 country.

France1 site

  • CHR Metz-Thionville/Hopital de Mercy

    Metz, 57085

Other trials in France

About this study

Official title: Real-life Study of the Efficacy of Management of Migraine Patients After Failure of 2 Prophylactic Treatments: a Retrospective Study

This is a real-life, observational, single-center cohort study to describe the efficacy of prophylactic treatment in patients after failure of at least 2 prophylactic treatments. Patients included in the study will be followed up in consultations or day hospitals according to their usual care, and will be asked to complete the MIgraine Disability Assessment (MIDAS), Headache Impact Test short-form (HIT-6), Patient Global Impression of Change (PGIC), Hospital Anxiety and Depression (HAD) scale and Work and Personal Activities Impairment (WPAI) questionnaires at each visit.

Data describing their care will be extracted from computerized patient records.

Conditions
Migraine
Being tested
Patient health care observational follow up after 2 prophylactic tratments
Keywords
migraine, prophylactic treatment, real life
Medical subject headings
Migraine Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Patient health care observational follow up after 2 prophylactic tratmentsBehavioural

    Real-life, observational, single-center cohort study to describe the efficacy of prophylactic treatment in patients after failure of at least 2 prophylactic treatments. Patients included in the study will be followed up in consultations or day hospitals according to their usual care, and will be asked to complete the MIDAS, HIT-6, PGIC, HAD and WPAI questionnaires at each visit. Data describing their care will be extracted from computerized patient records.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Headache Impact Test in patients with migraine at 12 months

    Using HIT-6 (Headache Impact Test short-form) questionnaire which addresses six main domains affected by headaches, including pain, social functioning, role functioning, cognitive functioning, vitality and psychological stress. This survey is extremely useful for screening and monitoring how headaches affect patients in their day-to-day lives over time.

    Each item is answered on a 5-point Likert scale (6 = never, 8 = rarely, 10 = sometimes, 11 = very often, 13 = always). The scoring of the HIT-6 was derived to approximate the total score obtained from a larger battery of items, using results from item response theory (IRT) [10]. The final score is obtained from simple summation of the six items.

    Measured: 12 months after prophylactic treatments

Secondary outcomes (10)

  1. Headache-related disability in patients with migraine at 12 months

    MIDAS scale (Migraine Disability Assessment) measures headache-related disability and improve doctor-patient communication about the functional consequences of migraine. The questionnaire was based on five disability questions that focus on lost time in three domains: schoolwork or work for pay; household work or chores; and family, social, and leisure activities.

    This instrument is scored as follows: 5 to 10 indicates little or no disability, 10 to 20 indicates moderate disability, and higher than 20 denotes severe disability.

    Measured: 12 months after prophylactic treatments

  2. Anxiety and Depression state evaluation in patients with migraine at 12 months

    Using Hospital Anxiety and Depression Scale (HADS) : is a 14-item measure designed to assess anxiety and depression symptoms in medical patients, with emphasis on reducing the impact of physical illness on the total score.

    The depression items tend to focus on the anhedonic symptoms of depression. Items are rated on a 4-point severity scale.

    The HADS produces two scales, one for anxiety (HADS-A) and one for depression (HADS-D), differentiating the two states. Scores of greater than or equal to 11 on either scale indicate a definitive case.

    Measured: 12 months after prophylactic treatments

  3. Migraine occurence in patients with migraine at 12 months

    Number of migraine days

    Measured: 12 months after prophylactic treatments

  4. Crisis treatments in patients with migraine at 12 months

    Number of crisis treatments taken

    Measured: 12 months after prophylactic treatments

  5. Patient Global Impression of Change in patients with migraine at 12 months

    Using Patient Global Impression of Change (PGIC) score: a 7 point scale depicting a patient's rating of overall improvement.

    Patients rate their change as "very much improved," "much improved," "minimally improved," "no change," "minimally worse," "much worse," or "very much worse."

    Measured: 12 months after prophylactic treatments

  6. Work and Personal Activities Impairment in patients with migraine at 12 months

    Using Work and Personal Activities Impairment (WPAI) score : a well validated instrument to measure impairments in work and activities.

    WPAI scores are based on 1-item (presenteeism, activitity impairment), 2-items (absenteeism) and multiple items (overall work productivity).

    Measured: 12 months after prophylactic treatments

  7. Most Bothersome Symptom in patients with migraine at 12 months

    Most Bothersome Symptom (MBS)

    Measured: 12 months after prophylactic treatments

  8. Days off work at 12 months

    Number of days off work

    Measured: 12 months after prophylactic treatments

  9. Emergency room visits at 12 months

    Number of emergency room visits

    Measured: 12 months after prophylactic treatments

  10. Type of prophylactic treatment used at 12 months

    Type of prophylactic treatment

    Measured: 12 months after prophylactic treatments

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jul 2023
  2. Study start1 Jun 2023
  3. Primary completion1 Mar 2024
  4. Study completion1 Mar 2024

Resources

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
Retrospective
Enrolment
127 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05947123
Sponsor's protocol ID
2023-07Obs-CHRMT
Acronym
EVIREMIG
Status last verified
Aug 2024
First submitted
7 Jul 2023
Last updated
9 Aug 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Migraine, run by Centre Hospitalier Régional Metz-Thionville at 1 site in France.

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 5 inclusion and 3 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: finished, as of the sponsor's last update on 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Headache Impact Test in patients with migraine at 12 months (time frame: 12 months after prophylactic treatments). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05947123.

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 9 Aug 2024.

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