MigrainePASENREGENCT05780580
Prescription of Triptans in the Grand Est Region, France
An observational study of Migraine, run by Centre Hospitalier Régional Metz-Thionville at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Migraine
- How many people
- 4,275,652 participants
- Where
- 1 siteFrance
- Study dates
- 15 Jul 2020to 30 Jul 2020
- 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 12 years and older
- All sexes
- Child, Adult, Older adult
Study population: Patients with migraine
Who may be able to join
- beneficiary of the general health insurance scheme between june 2018 and june 2019
- at least 12 years old
- resident in the Grand Est region
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Characteristics of Health Insurance Beneficiaries With a Triptan Prescription in the Grand Est Region, France, in 2018-2019 - PASENREGE Study
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.
- Conditions
- Migraine
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| patients with a prescription for triptan reimbursed by health insurance | Not described | |
| patients without a prescription for triptan reimbursed by health insurance | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
prescription for triptan
Number of insureds with at least one reimbursement for a triptan prescription between June 2018 and June 2019
Measured: 1 year
Secondary outcomes (1)
quantity of triptan consumption
number of boxes of triptans dispensed per insured person, weighted by the number of doses contained per box
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2023
- Study start15 Jul 2020
- Primary completion15 Jul 2020
- Study completion30 Jul 2020
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.
- 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
- Retrospective
- Enrolment
- 4,275,652 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Régional Metz-Thionville
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xavier DUCROCQ, MD,, Principal investigator, CHR Metz Thionville Hopital de Mercy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05780580
- Sponsor's protocol ID
- 2023-02Obs-CHRMT
- Acronym
- PASENREGE
- Status last verified
- Mar 2023
- First submitted
- 10 Mar 2023
- Last updated
- 22 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characteristics of Health Insurance Beneficiaries With a Triptan Prescription in the Grand Est Region, France, in 2018-2019 - PASENREGE Study
- ClinicalTrials.gov ID
- NCT05780580
- Acronym / sponsor ID
- PASENREGE / 2023-02Obs-CHRMT
- Conditions
- Migraine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,275,652 participants (actual)
- Lead sponsor
- Centre Hospitalier Régional Metz-ThionvilleUniversity, hospital or other
- Study start
- 15 Jul 2020 (actual)
- Primary completion
- 15 Jul 2020 (actual)
- Study completion
- 30 Jul 2020 (actual)
- First posted
- 22 Mar 2023 (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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with a prescription for triptan reimbursed by health insurance | – | – |
| patients without a prescription for triptan reimbursed by health insurance | – | – |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with migraine
Key inclusion criteria (3 listed)
- beneficiary of the general health insurance scheme between june 2018 and june 2019
- at least 12 years old
- resident in the Grand Est region
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
prescription for triptan
Time frame: 1 year
Number of insureds with at least one reimbursement for a triptan prescription between June 2018 and June 2019
1 secondary outcome
quantity of triptan consumption
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2023.
- Individual participant dataSharing planned: No
Related trials for Migraine
RecruitingObservational study
Study of the Glymphatic System in Migraine
Migraine
Active, not recruiting
Clinical and Neurophysiological Effects of tDCS to Visual and Motor Cortex in Migraine
Migraine
Active, not recruiting
App-Based Migraine Treatment: The Health enSuite Study
Migraine, Migraine With Aura
Not yet recruiting
A Prospective Study of Rimegepant for Short-term Preventive Treatment of Night-shift-related Migraine in Healthcare Professionals
Migraine Disorders
Recruiting
Marine Lipids Ease Painful TMD
Temporomandibular Disorder (TMD)
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.
Xavier DUCROCQ, MD, principal investigator
CHR Metz Thionville Hopital de Mercy
1 site in 1 country: see every site and its status.
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 3 inclusion and 1 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 22 Mar 2023. 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?
prescription for triptan (time frame: 1 year). 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 22 Mar 2023.