MigraineEPTI-CONCT06446804
Follow-up of Migraine Patients on Eptinezumab
An observational study of Migraine, run by Centre Hospitalier Universitaire de Nīmes at 2 sites in France.
Trial summary
The October 2022 Transparency Commission considers that VYEPTI (eptinezumab) is a treatment option for patients suffering from severe migraine with at least 8 migraine days per month, who have failed at least two prophylactic treatments and have no cardiovascular impairment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Migraine
- What is being tested?
- None, pure observationnal study
- How many people
- 60 participants
- Where
- 2 sitesFrance
- Study dates
- 1 Jun 2024to 31 Aug 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: Consecutive patients with severe migraine with at least 8 migraine days per month and failure of at least 2 disease-modifying therapies, treated with quarterly infusions of eptinezumab since March 2023 in a day hospital at the Saint-Denis hospital and the Nîmes university hospital.
Who may be able to join
- Adult patients suffering from severe migraine with at least 8 migraine days per month
- Patients who have failed at least 2 disease-modifying treatments,
- Patients treated with quarterly infusions of eptinezumab since March 2023 in a day hospital at Saint-Denis Hospital and Nîmes University Hospital.
Who cannot join
- Patient refusing to participate
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Feedback on the Use of Eptinezumab: Efficacy at 6 Months in Severe Migraine
The October 2022 Transparency Commission considers that VYEPTI (eptinezumab) is a treatment option for patients suffering from severe migraine with at least 8 migraine days per month, who have failed at least two prophylactic treatments and have no cardiovascular impairment.
Since the beginning of 2023, eptinezumab has been available in France as an inpatient treatment prescribed by a migraine neurologist in a growing number of centres. The Saint-Denis Hospital and the Nîmes University Hospital are among the first centres to have started. The investigators from these 2 centres have therefore decided to pool their data to provide the first French feedback on its effectiveness.
- Conditions
- Migraine
- Being tested
- None, pure observationnal study
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
None, pure observationnal studyOther
Pure observatonnal study
| Study group | Role | What they receive |
|---|---|---|
| Migraine patients | Patients with severe migraine, with at least 8 migraine days per month and at least 2 failed background treatments. Receives: Other: None, pure observationnal study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Headaches and migraines per month
Number of headache and migraine days per month.
Measured: 6 months
Responders
Rate of responders (30%, 50% and super responders > 75%)
Measured: 6 months
Duration
Duration of effect of eptinezumab infusion (Numbers of weeks)
Measured: 6 months
HIT6 scores (disability score)
Evaluation of HIT6 scores (disability score),
≤ 49 headaches have little impact on daily life; between 50 and 55: headaches have some impact on daily life; 56 to 59: headaches have a significant impact on daily life; ≥ 60
Measured: 6 months
HAD (anxiety/depression score)
Evaluation of HAD score. From 0 to 7: absence of anxiety and/or depressive disorders, from 8 to 10: doubtful symptomatology, 11 to 21: proven anxiety and/or depression disorders of varying severity.
Measured: 6 months
Concomitant treatments
Use of concomitant crisis and background treatments (description)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2024
- Study start1 Jun 2024
- Primary completion31 Aug 2024
- Study completion31 Aug 2024
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 Centre Hospitalier Universitaire de NīmesThe 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anissa MEGZARI, Study director, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06446804
- Sponsor's protocol ID
- LOCAL/2024/AL-01
- Acronym
- EPTI-CO
- Status last verified
- Oct 2024
- First submitted
- 30 May 2024
- Last updated
- 1 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feedback on the Use of Eptinezumab: Efficacy at 6 Months in Severe Migraine
- ClinicalTrials.gov ID
- NCT06446804
- Acronym / sponsor ID
- EPTI-CO / LOCAL/2024/AL-01
- Conditions
- Migraine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 31 Aug 2024 (actual)
- Study completion
- 31 Aug 2024 (actual)
- First posted
- 6 Jun 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 October 2022 Transparency Commission considers that VYEPTI (eptinezumab) is a treatment option for patients suffering from severe migraine with at least 8 migraine days per month, who have failed at least two prophylactic treatments and have no cardiovascular impairment.
Since the beginning of 2023, eptinezumab has been available in France as an inpatient treatment prescribed by a migraine neurologist in a growing number of centres. The Saint-Denis Hospital and the Nîmes University Hospital are among the first centres to have started. The investigators from these 2 centres have therefore decided to pool their data to provide the first French feedback on its effectiveness.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Migraine patients | – | Other: None, pure observationnal studyPatients with severe migraine, with at least 8 migraine days per month and at least 2 failed background treatments. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients with severe migraine with at least 8 migraine days per month and failure of at least 2 disease-modifying therapies, treated with quarterly infusions of eptinezumab since March 2023 in a day hospital at the Saint-Denis hospital and the Nîmes university hospital.
Key inclusion criteria (3 listed)
- Adult patients suffering from severe migraine with at least 8 migraine days per month
Key exclusion criteria (1 listed)
- Patient refusing to participate
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 |
|---|---|---|
| None, pure observationnal studyPure observatonnal study | Other | Migraine patients |
Primary outcome
Headaches and migraines per month
Time frame: 6 months
Number of headache and migraine days per month.
Responders
Time frame: 6 months
Rate of responders (30%, 50% and super responders > 75%)
Duration
Time frame: 6 months
Duration of effect of eptinezumab infusion (Numbers of weeks)
HIT6 scores (disability score)
Time frame: 6 months
Evaluation of HIT6 scores (disability score), ≤ 49 headaches have little impact on daily life; between 50 and 55: headaches have some impact on daily life; 56 to 59: headaches have a significant impact on daily life; ≥ 60
HAD (anxiety/depression score)
Time frame: 6 months
Evaluation of HAD score. From 0 to 7: absence of anxiety and/or depressive disorders, from 8 to 10: doubtful symptomatology, 11 to 21: proven anxiety and/or depression disorders of varying severity.
Concomitant treatments
Time frame: 6 months
Use of concomitant crisis and background treatments (description)
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 1 Nov 2024.
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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.
Anissa MEGZARI study director
Centre Hospitalier Universitaire de Nīmes
2 sites 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 Universitaire de Nīmes at 2 sites 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 1 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Headaches and migraines per month (time frame: 6 months). The study lists 6 primary outcomes in all. 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 1 Nov 2024.