Ditan Acute tReatments: Effectiveness and Tolerability (DART)

University of Florence (UNIFI)

Status

Completed

Conditions

Migraine With Aura

Chronic Migraine

Migraine Without Aura

Migraine

Treatments

Drug: Lasmiditan

Study type

Observational

Funder types

Other

Identifiers

NCT05903040

RICe_2

Details and patient eligibility

About

The purpose of this prospective and multicentric study is to evaluate the effectiveness and tolerability of lasmiditan as acute migraine treatment in a cohort of episodic or chronic migraine patients.

Full description

Lasmiditan is a serotonin 5-HT1F receptor agonist. It is available in three different dosages (namely 50, 100 and 200 mg) with oral administration. Phase 3 double-blind randomized controlled studies demonstrated its effectiveness 2h post-dose in a single migraine attack and consistent effectiveness across four different attacks.

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.

Enrollment

100 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Diagnosis of migraine without aura, migraine with aura, or chronic migraine according to the 3rd edition of the International Classification of Headache Disorder (ICHD-III).

At least 3 MMDs

Good compliance to study procedures
Availability of headache diary at least of the preceding months before enrollment

Exclusion criteria

Subjects with contraindications for use of ditans;
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.