Ditan Acute tReatments: Effectiveness and Tolerability (DART)

NCT05903040 | Completed DMC

• 1 other identifier: RICe_2
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Chronic Migraine; Migraine; Migraine With Aura; Migraine Without Aura

Keywords

Headache; Medication overuse headache; Pain; Ditan; Triptan

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (10)

• Headache pain freedom at 2 hours post dose across all treated attacks

  2 hours post-dose for all treated attacks

• Headache pain relief at 2 hours post-dose during the first attack

  2 hours post-dose

• Headache pain relief at 2 hours post-dose across all treated attacks

  2 hours post-dose for all treated attacks

• Ability to function normally at 2 hours post-dose during the first attack

  2 hours post-dose

• Ability to function normally at 2 hours post-dose across all treated attacks

  2 hours post-dose for all treated attacks

Study Arms (2)

Episodic migraine

Patients affected by an episodic pattern (\< 15 monthly headache days) migraine with or without aura according to ICHD-III criteria.

Drug: Lasmiditan

Chronic migraine

Patients affected by chronic migraine according to ICHD-III criteria.

Drug: Lasmiditan

Interventions

Lasmiditan DRUG

Patients using Lasmiditan 50-100-200 mg oral tablet to treat acute migraine attacks

Chronic migraine; Episodic migraine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (2)

SOD Centro Cefalee e Farmacologia Clinica, AOU Careggi

Florence, 50134, Italy

Location

IRCCS National Neurological Institute "C. Mondino" Foundation

Pavia, 27100, Italy

Location

Related Publications (3)

• 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.

  PMID: 33541117 BACKGROUND

• 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.

  PMID: 31132795 BACKGROUND

• 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.

  PMID: 41446321 DERIVED

MeSH Terms

Conditions

Migraine Disorders; Migraine with Aura; Migraine without Aura; Headache; Headache Disorders, Secondary; Pain

Interventions

lasmiditan

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: June 5, 2023
• First Posted: June 15, 2023
• Study Start: June 15, 2023
• Primary Completion: June 1, 2024
• Study Completion: December 1, 2025
• Last Updated: January 21, 2026

Record last verified: 2026-01

Locations

IT (2)