Ditan Acute tReatments: Effectiveness and Tolerability (DART) (DART)

Effectiveness and Tolerability of Lasmiditan as Acute Migraine Treatment: a Prospective, Multicentric, Cohort Study

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.

Study Overview

• Status: Completed
• Conditions: Migraine; Chronic Migraine; Migraine Without Aura; Migraine With Aura
• Intervention / Treatment: Drug: Lasmiditan

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Italy
  • Florence, Italy, 50134
    • SOD Centro Cefalee e Farmacologia Clinica, AOU Careggi
  • Pavia, Italy, 27100
    • IRCCS National Neurological Institute "C. Mondino" Foundation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Multicentric study on patients attending the outpatient clinic of Italian Headache centres who meet criteria for lasmiditan use for acute migraine treatments.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Chronic migraine; Patients affected by chronic migraine according to ICHD-III criteria.	Drug: Lasmiditan; Patients using Lasmiditan 50-100-200 mg oral tablet to treat acute migraine attacks
Episodic migraine; Patients affected by an episodic pattern (< 15 monthly headache days) migraine with or without aura according to ICHD-III criteria.	Drug: Lasmiditan; Patients using Lasmiditan 50-100-200 mg oral tablet to treat acute migraine attacks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Headache pain freedom at 2 hours post dose during the first attack	The percentage of subjects that report no headache pain at 2 hours after drug intake. Pain will be measured on a 4 point Likert scale (0=none, 1=mild, 2=moderate, 3=severe).	2 hours post-dose
Occurrence of treatment-emergent adverse events	To evaluate the safety and tolerability of Lasmiditan in migraine subjects	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Headache pain relief at 2 hours post-dose during the first attack	The percentage of subjects that report mild or none headache pain at 2 hours after drug intake during the first attack. Pain will be measured on a 4 point Likert scale (0=none, 1=mild, 2=moderate, 3=severe).	2 hours post-dose
Headache pain relief at 2 hours post-dose across all treated attacks	The percentage of subjects that report mild or none headache pain at 2 hours after drug intake across all treated attack. Pain will be measured on a 4 point Likert scale (0=none, 1=mild, 2=moderate, 3=severe).	2 hours post-dose for all treated attacks
Freedom from the most bothersome symptom (MBS) associated with migraine at 2 hours post-dose during the first attack	The percentage of subjects that report complete MBS resolution at 2 hours after drug intake. MBS will be measured on a 4 point Likert scale (0=none, 1=mild, 2=moderate, 3=severe).	2 hours post-dose
Headache recurrence for the first-attack	Percentage of subjects who became pain free at 2 hours post-dose and report new headache pain within 24 hours post-dose.	between 2 hours and 24 hours post-dose
Rescue medications use for the first attack	Percentage of subjects who take a rescue medication after 2 hour post-dose. Rescue medications will be measured using a binary scale (0=no consumption, 1=consumption)	between 2 hours and 24 hours post dose
Treatment satisfaction	Level of patients' self-reported satisfaction which will be measured on a 0-10 visual analogue scale (0=no satisfaction, 10= the highest satisfaction) and Patients Global Impression of Change (0= no changing, 7= a change that makes the difference).	2 hours post-dose for all treated attacks
Self-reported treatment effectiveness	Level of patients' self-reported treatment effectiveness measured by Migraine Assessment of Current Therapy (migraine ACT) a 4-item questionnaire about treatment effectiveness and daily life repercussions.	12 weeks
Headache pain freedom at 2 hours post dose across all treated attacks	The percentage of subjects that report no headache pain at 2 hours after drug intake across all' treated attacks. Pain will be measured on a 4 point Likert scale (0=none, 1=mild, 2=moderate, 3=severe).	2 hours post-dose for all treated attacks
Ability to function normally at 2 hours post-dose during the first attack	The percentage of subjects that self-report no functional disability at 2 hours post-dose. Functional disability will be assessed through the Functional Disability Scale (FDS), a four-point scale: normal, mildly impaired, severely impaired, requires daily activities interruption.	2 hours post-dose
Ability to function normally at 2 hours post-dose across all treated attacks	The percentage of subjects that self-report no functional disability at 2 hours post-dose. Functional disability will be assessed through the Functional Disability Scale (FDS), a four-point scale: normal, mildly impaired, severely impaired, requires daily activities interruption.	2 hours post-dose for all treated attacks

Collaborators and Investigators

• Sponsor: University of Florence
• Collaborators: University of Roma La Sapienza; Azienda Ospedaliero-Universitaria di Parma; Azienda Ospedaliera S. Maria della Misericordia; IRCCS National Neurological Institute "C. Mondino" Foundation; Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari; Università degli Studi dell'Aquila; Azienda Policlinico Umberto I; Cliniche Humanitas Gavazzeni; Carlo Besta Neurological Institute; Ospedale Santo Stefano; Azienda Ospedaliero Universitaria Policlinico Modena; Ospedale di Piove di Sacco; A.O.U. Città della Salute e della Scienza; Asst Degli Spedali Civili Di Brescia; University of Campania Luigi Vanvitelli; Società Italiana per lo Studio delle Cefalee; Auxologico San Luca

Publications and helpful links

General Publications

• 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.
• Vaghi G, Iannone LF, Corrado M, De Santis F, Romozzi M, Sebastianelli G, Dalla Volta G, Bolchini M, Burgalassi A, De Cesaris F, Albanese M, Mercuri Biagio N, Ornello R, Sacco S, Pistoia F, Saporito G, Casillo F, Avino G, Granato A, Russo A, Silvestro M, Vollono C, Trimboli M, Doretti A, Valente M, Cevoli S, Mampreso E, Tassorelli C, De Icco R. Effectiveness and tolerability of lasmiditan in the acute treatment of migraine: a real-world, prospective, multicentric study (DART study). Ther Adv Neurol Disord. 2025 Dec 21;18:17562864251381886. doi: 10.1177/17562864251381886. eCollection 2025.

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2023
• Primary Completion (Actual): June 1, 2024
• Study Completion (Actual): December 1, 2025

Study Registration Dates

• First Submitted: June 5, 2023
• First Submitted That Met QC Criteria: June 5, 2023
• First Posted (Actual): June 15, 2023

Study Record Updates

• Last Update Posted (Actual): January 21, 2026
• Last Update Submitted That Met QC Criteria: January 19, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Pain; Headache; Medication overuse headache; Triptan; Ditan
• Additional Relevant MeSH Terms: Neurologic Manifestations; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Migraine Disorders; Headache; Migraine with Aura; Migraine without Aura; Headache Disorders, Secondary; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Serotonin Agents; Serotonin Receptor Agonists; lasmiditan
• Other Study ID Numbers: RICe_2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No