NCT05780580

Brief Summary

The high frequency of migraine contrasts with the disparity of its management. The FRAMIG 3 study, carried out in France on the basis of the definition criteria of migraine of the IHS 2004 classification, identified, on the basis of a questionnaire of a representative sample of the general population of 10532 people, 11.2% of the people meeting the criteria of defined migraine and 10.1% of the criteria of probable migraine. Only 40.2% knew they had migraine. 50% used self-medication. Although available since the late 1990s as an effective and specific treatment for migraine attacks, 7.5% of migraineurs in the FRAMIG 3 study used a triptan. In 2003-4, 1.5% of the 1,793,000 inhabitants of Alsace had received at least one prescription for triptans over a one-year period. 1.9% of them were considered overconsumers (greater than or equal to 144 doses/year). More than 10 years later, another population-based study, using data from the French national health agency, identified 1.8% of insured persons receiving a triptan. Several migraine prophylactic treatments have been shown to be effective in patients with frequent or severe migraine attacks, or who do not respond to crisis treatment, or who claim poor quality of life due to migraine, but only 50% of candidates for such prophylactic treatment were receiving it. Only 1.5% of migraine patients in the FRAMIG 3 study were taking prophylaxis. Quality of life was impaired in 57% of migraineurs in the USA and in 28% of French migraineurs. In Ali's study (Ali 2017), 6.9% of migraineurs had used a neurologist. A Brazilian study shows that the average delay of patients accessing a tertiary center was 17 years. As promising new prophylactic treatments become available, we wanted to study a population of migraineurs identified on the basis of a triptan prescription, in order to try to better identify the characteristics of this population, particularly in terms of analgesic consumption and use of specialized care. The objective of this study was to describe the quantity of triptans dispensed to residents of the Grand Est region aged 12 years and older, between June 1, 2018, and June 1, 2019, based on health insurance data. The secondary objectives were to compare the characteristics of insured persons who had at least one triptan dispensing with those of other insured persons, and to compare the characteristics of insured persons by quantity of triptans dispensed.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
4,275,652

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 15, 2020

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2020

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2020

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

March 10, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 22, 2023

Completed
Last Updated

March 22, 2023

Status Verified

March 1, 2023

Enrollment Period

Same day

First QC Date

March 10, 2023

Last Update Submit

March 10, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • prescription for triptan

    Number of insureds with at least one reimbursement for a triptan prescription between June 2018 and June 2019

    1 year

Secondary Outcomes (1)

  • quantity of triptan consumption

    1 year

Study Arms (2)

patients with a prescription for triptan reimbursed by health insurance

patients without a prescription for triptan reimbursed by health insurance

Eligibility Criteria

Age12 Years+
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with migraine

You may qualify if:

  • beneficiary of the general health insurance scheme between june 2018 and june 2019
  • at least 12 years old
  • resident in the Grand Est region

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHR Metz-Thionville/Hopital de Mercy

Metz, 57085, France

Location

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Xavier DUCROCQ, MD,

    CHR Metz Thionville Hopital de Mercy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 10, 2023

First Posted

March 22, 2023

Study Start

July 15, 2020

Primary Completion

July 15, 2020

Study Completion

July 30, 2020

Last Updated

March 22, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations