Ditan Acute tReatments: Effectiveness and Tolerability (DART)

Recruiting

• Conditions: Migraine; Migraine With Aura; Migraine Without Aura; Chronic Migraine
• Interventions: Drug: Lasmiditan

• Registration Number: NCT05903040
• Lead Sponsor: University of Florence

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.

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 Timeline

• Study First Submitted: 2023-06-05
• Study First Submitted QC: 2023-06-05
• Study Start: 2023-06-15
• Study First Posted: 2023-06-15
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-02
• Last Update Posted: 2023-12-08
• Primary Completion: 2024-06
• Study Completion: 2024-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Episodic migraine	Lasmiditan	Patients affected by an episodic pattern (\< 15 monthly headache days) migraine with or without aura according to ICHD-III criteria.
Chronic migraine	Lasmiditan	Patients affected by chronic migraine according to ICHD-III criteria.

Primary Outcome Measures

Name	Time	Method
Occurrence of treatment-emergent adverse events	12 weeks	To evaluate the safety and tolerability of Lasmiditan in migraine subjects
Headache pain freedom at 2 hours post dose during the first attack	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).

Secondary Outcome Measures

Name	Time	Method
Freedom from the most bothersome symptom (MBS) associated with migraine at 2 hours post-dose during the first attack	2 hours post-dose	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).
Headache pain relief at 2 hours post-dose during the first attack	2 hours post-dose	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).
Headache pain relief at 2 hours post-dose across all treated attacks	2 hours post-dose for 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).
Headache recurrence for the first-attack	between 2 hours and 24 hours post-dose	Percentage of subjects who became pain free at 2 hours post-dose and report new headache pain within 24 hours post-dose.
Headache pain freedom at 2 hours post dose across all treated attacks	2 hours post-dose for 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).
Rescue medications use for the first attack	between 2 hours and 24 hours post dose	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)
Self-reported treatment effectiveness	12 weeks	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.
Ability to function normally at 2 hours post-dose during the first attack	2 hours post-dose	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.
Ability to function normally at 2 hours post-dose across all treated attacks	2 hours post-dose for 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.
Treatment satisfaction	2 hours post-dose for all treated attacks	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).

Trial Locations

Locations (2)

SOD Centro Cefalee e Farmacologia Clinica, AOU Careggi; 🇮🇹 Florence, Italy

IRCCS National Neurological Institute "C. Mondino" Foundation; 🇮🇹 Pavia, Italy