Ditan Acute tReatments: Effectiveness and Tolerability (DART)
NCT ID: NCT05903040
Last Updated: 2023-12-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
100 participants
OBSERVATIONAL
2023-06-15
2024-06-30
Brief Summary
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Detailed Description
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The lack of vasoconstrictive activity allow its use also in patients with cardiovascular medical history. This finding was also confirmed in a real-world study. As it is a small molecule with access to the central nervous system predominant adverse events are CNS-related (as dizziness, somnolence and paraesthesia).
In this prospective multicentric study the Investigators aim to evaluate lasmiditan effectiveness and tolerability as acute migraine treatment in a real-world setting. Subjects who meet the inclusion criteria will be enrolled and will participate in the study. Baseline demographic and clinical data will be collected at the baseline. Patients will be asked to treat their next migraine attack with lasmiditan 50 - 100 - 200 mg oral tablet.
Data will be collected at baseline, during at least 4 migraine attacks treated with lasmiditan and at 3 months follow-up.
Subjects will be asked to complete assessment of their migraine attack at baseline and at 30 - 60 - 90 and 120 minutes after administration of the acute treatment for at least four migraine attacks. A final timepoint at 24 hours post-dose will be assessed only for the first attack.
Data collection will focus on: i) demographic data, ii) migraine history, iii) pain level and evolution, iv) presence and evolution of migraine associated symptoms, most bothersome symptom and aura, v) migraine associated disability, vi) patients's global impression of change (PGIC) and evaluation on the acute treatment (Migraine-ACT), vii) tolerability and eventual treatment-emergent adverse events. The online database REDCap will be used for data collection.
Conditions
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Keywords
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Episodic migraine
Patients affected by an episodic pattern (\< 15 monthly headache days) migraine with or without aura according to ICHD-III criteria.
Lasmiditan
Patients using Lasmiditan 50-100-200 mg oral tablet to treat acute migraine attacks
Chronic migraine
Patients affected by chronic migraine according to ICHD-III criteria.
Lasmiditan
Patients using Lasmiditan 50-100-200 mg oral tablet to treat acute migraine attacks
Interventions
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Lasmiditan
Patients using Lasmiditan 50-100-200 mg oral tablet to treat acute migraine attacks
Eligibility Criteria
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Inclusion Criteria
At least 3 MMDs
* Good compliance to study procedures
* Availability of headache diary at least of the preceding months before enrollment
Exclusion Criteria
* Concomitant diagnosis of medical diseases and/or comorbidities that, in the Investigator's opinion might interfere with study assessments;
* medical comorbidities that could interfere with study results;
* Pregnancy and breastfeeding.
18 Years
ALL
No
Sponsors
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IRCCS National Neurological Institute "C. Mondino" Foundation
OTHER
Società Italiana per lo Studio delle Cefalee
OTHER
Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
OTHER
Università degli Studi dell'Aquila
OTHER
University of Roma La Sapienza
OTHER
Azienda Ospedaliero Universitaria Policlinico Modena
OTHER
Ospedale di Piove di Sacco
UNKNOWN
Azienda Ospedaliero-Universitaria di Parma
OTHER
Azienda Ospedaliera S. Maria della Misericordia
OTHER
A.O.U. Città della Salute e della Scienza
OTHER
Cliniche Humanitas Gavazzeni
OTHER
University of Campania Luigi Vanvitelli
OTHER
Ospedale Santo Stefano
OTHER
Azienda Policlinico Umberto I
OTHER
Auxologico San Luca
OTHER
Asst Degli Spedali Civili Di Brescia
OTHER
Carlo Besta Neurological Institute
OTHER
University of Florence
OTHER
Responsible Party
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Luigi Francesco Iannone
Researcher
Locations
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SOD Centro Cefalee e Farmacologia Clinica, AOU Careggi
Florence, , Italy
IRCCS National Neurological Institute "C. Mondino" Foundation
Pavia, , Italy
Countries
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Central Contacts
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Facility Contacts
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Luigi F Iannone, MD
Role: primary
Roberto De Icco, MD
Role: primary
References
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Ashina M, Reuter U, Smith T, Krikke-Workel J, Klise SR, Bragg S, Doty EG, Dowsett SA, Lin Q, Krege JH. Randomized, controlled trial of lasmiditan over four migraine attacks: Findings from the CENTURION study. Cephalalgia. 2021 Mar;41(3):294-304. doi: 10.1177/0333102421989232. Epub 2021 Feb 4.
Goadsby PJ, Wietecha LA, Dennehy EB, Kuca B, Case MG, Aurora SK, Gaul C. Phase 3 randomized, placebo-controlled, double-blind study of lasmiditan for acute treatment of migraine. Brain. 2019 Jul 1;142(7):1894-1904. doi: 10.1093/brain/awz134.
Other Identifiers
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RICe_2
Identifier Type: -
Identifier Source: org_study_id