MigraineDARTNCT05903040
Ditan Acute tReatments: Effectiveness and Tolerability (DART)
An observational study of Migraine and Migraine With Aura, run by University of Florence at 2 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Migraine, Migraine With Aura, Migraine Without Aura
- What is being tested?
- Lasmiditan
- Type of treatment
- Pill or oral medicine
- How many people
- 100 participants
- Where
- 2 sitesItaly
- Study dates
- 15 Jun 2023to 1 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Multicentric study on patients attending the outpatient clinic of Italian Headache centres who meet criteria for lasmiditan use for acute migraine treatments.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
SOD Centro Cefalee e Farmacologia Clinica, AOU Careggi
Florence, 50134
IRCCS National Neurological Institute "C. Mondino" Foundation
Pavia, 27100
About this study
Official title: 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.
Read the 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.
- Conditions
- Migraine, Migraine With Aura, Migraine Without Aura, Chronic Migraine
- Being tested
- Lasmiditan
- Keywords
- Headache, Medication overuse headache, Pain, Ditan, Triptan
- Medical subject headings
- Migraine Disorders, Migraine with Aura, Migraine without Aura, Headache, Headache Disorders, Secondary, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LasmiditanDrug
Patients using Lasmiditan 50-100-200 mg oral tablet to treat acute migraine attacks
| Study group | Role | What they receive |
|---|---|---|
| Episodic migraine | Patients affected by an episodic pattern (< 15 monthly headache days) migraine with or without aura according to ICHD-III criteria. Receives: Drug: Lasmiditan | |
| Chronic migraine | Patients affected by chronic migraine according to ICHD-III criteria. Receives: Drug: Lasmiditan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 2 hours post-dose
Occurrence of treatment-emergent adverse events
To evaluate the safety and tolerability of Lasmiditan in migraine subjects
Measured: 12 weeks
Secondary outcomes (10)
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).
Measured: 2 hours post-dose for all treated attacks
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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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)
Measured: 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).
Measured: 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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study start15 Jun 2023
- Primary completion1 Jun 2024
- Study completion1 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florence
- Sponsor type
- University, hospital or other
- Collaborators
- IRCCS National Neurological Institute "C. Mondino" Foundation, Società Italiana per lo Studio delle Cefalee, Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari, Università degli Studi dell'Aquila, University of Roma La Sapienza, Azienda Ospedaliero Universitaria Policlinico Modena, ULSS6 - Ospedale di Piove di Sacco, Azienda Ospedaliero-Universitaria di Parma, Azienda Ospedaliera S. Maria della Misericordia, A.O.U. Città della Salute e della Scienza, Cliniche Humanitas Gavazzeni, University of Campania Luigi Vanvitelli, Ospedale Santo Stefano, Azienda Policlinico Umberto I, Auxologico San Luca, Asst Degli Spedali Civili Di Brescia, Carlo Besta Neurological Institute
- Responsible party
- Principal investigator, Luigi Francesco Iannone, University of Modena and Reggio Emilia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05903040
- Sponsor's protocol ID
- RICe_2
- Acronym
- DART
- Status last verified
- Jan 2026
- First submitted
- 5 Jun 2023
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 33541117Goadsby 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.
PubMed 31132795Vaghi G, Iannone LF, Sebastianelli G, Piella EM, Corrado M, Romozzi M, De Santis F, Ornello R, Pistoia F, De Cesaris F, Burgalassi A, Coppola G, Silvestro M, Rainero I, Volta GD, Montisano DA, Guerzoni S, Prudenzano MP, Mascarella D, Avino G, Mampreso E, Valente M, Battistini S, Granato A, Albanese M, Trimboli M, Doretti A, De Icco R; Italian Headache Registry (RICe) Study Group. Effectiveness and safety of lasmiditan and rimegepant in the acute migraine treatment: an indirect real-world comparison. Neurol Sci. 2026 Nov 5;47(11):917. doi: 10.1007/s10072-026-09510-6.
PubMed 42982941Vaghi 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.
PubMed 41446321
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Tolerability of Lasmiditan as Acute Migraine Treatment: a Prospective, Multicentric, Cohort Study
- ClinicalTrials.gov ID
- NCT05903040
- Acronym / sponsor ID
- DART / RICe_2
- Conditions
- Migraine, Migraine With Aura, Migraine Without Aura, Chronic Migraine
- Keywords
- Headache, Medication overuse headache, Pain, Ditan, Triptan
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of FlorenceUniversity, hospital or other
- Collaborators
- IRCCS National Neurological Institute "C. Mondino" Foundation, Società Italiana per lo Studio delle Cefalee, Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari, Università degli Studi dell'Aquila, University of Roma La Sapienza, Azienda Ospedaliero Universitaria Policlinico Modena, ULSS6 - Ospedale di Piove di Sacco, Azienda Ospedaliero-Universitaria di Parma, Azienda Ospedaliera S. Maria della Misericordia, A.O.U. Città della Salute e della Scienza, Cliniche Humanitas Gavazzeni, University of Campania Luigi Vanvitelli, Ospedale Santo Stefano, Azienda Policlinico Umberto I, Auxologico San Luca, Asst Degli Spedali Civili Di Brescia, Carlo Besta Neurological Institute
- Study start
- 15 Jun 2023 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 15 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Episodic migraine | – | Drug: LasmiditanPatients affected by an episodic pattern (< 15 monthly headache days) migraine with or without aura according to ICHD-III criteria. |
| Chronic migraine | – | Drug: LasmiditanPatients affected by chronic migraine according to ICHD-III criteria. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Multicentric study on patients attending the outpatient clinic of Italian Headache centres who meet criteria for lasmiditan use for acute migraine treatments.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LasmiditanPatients using Lasmiditan 50-100-200 mg oral tablet to treat acute migraine attacks | Drug | Chronic migraine, Episodic migraine |
Primary outcome
Headache pain freedom at 2 hours post dose during the first attack
Time frame: 2 hours post-dose
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).
Occurrence of treatment-emergent adverse events
Time frame: 12 weeks
To evaluate the safety and tolerability of Lasmiditan in migraine subjects
10 secondary outcomes
Headache pain freedom at 2 hours post dose across all treated attacks
Time frame: 2 hours post-dose for all treated attacks
Headache pain relief at 2 hours post-dose during the first attack
Time frame: 2 hours post-dose
Headache pain relief at 2 hours post-dose across all treated attacks
Time frame: 2 hours post-dose for all treated attacks
Ability to function normally at 2 hours post-dose during the first attack
Time frame: 2 hours post-dose
Ability to function normally at 2 hours post-dose across all treated attacks
Time frame: 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
Time frame: 2 hours post-dose
Headache recurrence for the first-attack
Time frame: between 2 hours and 24 hours post-dose
Rescue medications use for the first attack
Time frame: between 2 hours and 24 hours post dose
Treatment satisfaction
Time frame: 2 hours post-dose for all treated attacks
Self-reported treatment effectiveness
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Background: PubMed 33541117Ashina 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.
- Background: PubMed 31132795Goadsby 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.
- Derived from this study: PubMed 42982941Vaghi G, Iannone LF, Sebastianelli G, Piella EM, Corrado M, Romozzi M, De Santis F, Ornello R, Pistoia F, De Cesaris F, Burgalassi A, Coppola G, Silvestro M, Rainero I, Volta GD, Montisano DA, Guerzoni S, Prudenzano MP, Mascarella D, Avino G, Mampreso E, Valente M, Battistini S, Granato A, Albanese M, Trimboli M, Doretti A, De Icco R; Italian Headache Registry (RICe) Study Group. Effectiveness and safety of lasmiditan and rimegepant in the acute migraine treatment: an indirect real-world comparison. Neurol Sci. 2026 Nov 5;47(11):917. doi: 10.1007/s10072-026-09510-6.
- Derived from this study: PubMed 41446321Vaghi 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.
- Individual participant dataSharing planned: Undecided
Related trials for Migraine
RecruitingObservational study
Study of the Glymphatic System in Migraine
Migraine
Active, not recruiting
Clinical and Neurophysiological Effects of tDCS to Visual and Motor Cortex in Migraine
Migraine
Active, not recruiting
App-Based Migraine Treatment: The Health enSuite Study
Migraine, Migraine With Aura
Not yet recruiting
A Prospective Study of Rimegepant for Short-term Preventive Treatment of Night-shift-related Migraine in Healthcare Professionals
Migraine Disorders
Recruiting
Marine Lipids Ease Painful TMD
Temporomandibular Disorder (TMD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Migraine and Migraine With Aura, run by University of Florence at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Headache pain freedom at 2 hours post dose during the first attack (time frame: 2 hours post-dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05903040, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.