Konzistence reakce s rimegepantem při akutní léčbě migrény (CORRELATE-UK)
Korelát-UK: Konzistence reakce s rimegepantem orálního lyofilikátu při akutní léčbě migrény ve Velké Británii
This is a non-interventional, prospective study that will enroll participants with migraine in the United Kingdom currently in use of rimegepant to acutely treat migraine attacks. Participants will be followed up for up to 12 weeks and will complete a daily questionnaire to self-report the consistency of response to rimegepant in acute treatment of migraine.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
This is a prospective observational, real-world cohort study of the patient-reported consistency of response to rimegepant in acute treatment of migraine. Longitudinal data capture will allow the determination of treatment effectiveness across multiple attacks, while the observational design will ensure the data reflect a real-world setting. In addition, a patient-centered real-time approach will allow for capture of granular data and will minimize patient recall bias, which is important for subjective outcomes such as pain. Patient reported outcome measures will be collected at study enrolment, daily during the 12-week observation period, and at the end of the study period.
The study will be conducted in the United Kingdom (UK). Potential participants will be identified and selected from UK healthcare institutions. Both patients diagnosed with episodic and chronic migraine will be included, with a split of approximately 50% of each group. Participants will be enrolled into the study over a period of approximately 6 months. The total data collection period will be approximately 9 months. Potentially eligible patients will receive briefing materials during a routine in-person consultation, or via email. Interested patients will use a link and a unique ID and PIN to complete a study eligibility screener within the study web application. The screener will consist of a series of demographic and clinical history questions. Participants who successfully complete the eligibility will then be able to proceed to the consent stage. Informed consent will also be provided within the study web application.
Consented participants will be required to complete a series of baseline demographic and clinical questions within a window of 72h from registration. A completion reminder will be sent every 24h until the completion window closes. Each participant will be followed up for 12 weeks. During this period, participants will receive an SMS with a link to the study website at the same time every day. A single click on the phone will take participants to the daily migraine survey. Two custom questions asking about migraine symptom occurrence and rimegepant use in the previous 24h will be presented to every participant daily from Day 1 to Day 84. A series of custom follow-up questions, asking further information about any migraine symptoms and related treatment, will be presented based on participant responses to questions 1 and 2 . A completion window of four days (96h) will be allowed for the daily questions. In case participants are still experiencing some migraine symptoms when prompted, they will be able to save their responses and return at a later time within the completion window. On Days 0, 28, 56 and 84 of follow-up, a menstruation question will be presented to all participants. At the end of the 12-week follow-up, the mTOQ-6 Likert version and the TSQM-II questionnaire will be presented to all participants.
Typ studie
Zápis (Odhadovaný)
Kontakty a umístění
Studijní místa
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-
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London, Spojené království
- Pfizer
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
Adult participants living in the United Kingdom, with a migraine diagnosis confirmed by a healthcare professional, experiencing at least 4 migraine attacks per month, with a current prescription of rimegepant for acute treatment of migraine, and, if receving preventive migraine treatment, must be stable before enrollment. Participants will be excluded if they are currently using rimegepant as preventive migraine treatment, if present other specific neurological conditions, if currently prescribed with drugs that may indude or inhibits CYP3A4, or if they are participating in a migraine-related clinical trial. All participants enrolled must acknowledge their participation in the study informed consent.
Popis
Inclusion criteria
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UK resident.
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At least 18 years of age.
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Migraine diagnosis confirmed by healthcare professional.
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Current prescription of rimegepant for acute treatment of migraine.
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Experienced at least 4 migraine attacks per month prior to study enrolment.
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In the case of participants receiving preventive migraine treatment:
- For oral preventives, the treatment must be "stable" i.e., final dosing regimen has been found.
- For migraine preventives administered monthly, the participant must have had their most recent treatment within the 3 weeks prior to study enrolment.
- For migraine preventives administered quarterly, the participant must have had their most recent treatment within the 2 months prior to study enrolment.
- If the last treatment is not within the stipulated period, participants will be asked to provide the date of the next scheduled treatment, after which the participant may be invited back to enrol into the study.
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Evidence of a personally signed (or acknowledged if obtained electronically or online) and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study.
Exclusion criteria
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Current use of rimegepant as a preventive migraine medication.
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Current diagnosis of any of the following conditions:
- new daily persistent headache
- chronic daily headache
- cluster headache
- post-traumatic headache
- hemicrania continua
- major depression
- pain syndromes other than migraine (e.g. fibromyalgia)
- psychiatric conditions (e.g., schizophrenia)
- dementia
- significant neurological disorders other than migraine.
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Current prescription of any of the following medications:
- Strong inhibitors of CYP3A4
- Strong or moderate inducers of CYP3A4
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Patients participating in a migraine-related clinical trial.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Observační modely: COHORT
- Časové perspektivy: PROSPECTIVE
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
|---|---|
|
Rimegepant users
Participants with current prescription of rimegepant for acute treatment of migraine |
Rimegepant for acute migraine treatment |
|
Rimegepant-treated attacks
Migraine attacks treated with rimegepant |
Rimegepant for acute migraine treatment |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Time to Meaninful Pain Relief (MPR) post-dosing
Časové okno: Daily (within 24hs post dose)
|
Proportion of rimegepant-treated attacks with reported MPR: within 1 hour post dose; 1-2 hours post dose; Over 2 hours up to 4 hours post dose; More than 4 hours post dose; who have not achieved MPR and took the medication more than 2 hours before completing the survey; who have not achieved MPR and took the medication less than 2 hours before completing the survey |
Daily (within 24hs post dose)
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Time to improvement in non-pain symptoms post-dosing
Časové okno: Daily (within 24hs post dose)
|
Proportion of rimegepant-treated attacks with reported improvement in any non-pain symptoms: within 1 hour post dose; 1-2 hours post dose; Over 2 hours up to 4 hours post dose; More than 4 hours post dose; who have not had a meaninful improvement and took the medication more than 2 hours before completing the survey; who have not had a meaninful improvement and took the medication less than 2 hours before completing the survey. |
Daily (within 24hs post dose)
|
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Acute migraine treatment optmization
Časové okno: 12 weeks follow up
|
Proportion of participants who reported treatment optimization using mTOQ6 questionnaire. Treatment optimization is categorized into: very poor treatment optimization, poor treatment optimization, moderate treatment optimization, maximum treatment optimization |
12 weeks follow up
|
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Acute migraine treatment optmization
Časové okno: 12 weeks follow up
|
Treatment satisfaction assessed using TSQM-II questionnaire. Domain scores (0-100) is presented for the following domains: effectiveness, Side effects, Convenience, and global satisfaction. Higher scores indicate greater satisfaction. Scores are reported separately for each domain. |
12 weeks follow up
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Ředitel studie: Pfizer CT.gov Call Center, Pfizer
Publikace a užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- C4951071
- CORRELATE-UK (Jiný identifikátor: Alias Study Number)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
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