Trial · NCT05903040
Ditan Acute tReatments: Effectiveness and Tolerability (DART)
NCT05903040, Completed, University of Florence
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Ditan Acute tReatments: Effectiveness and Tolerability (DART). Trials, record NCT05903040. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05903040
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Ditan Acute tReatments: Effectiveness and Tolerability (DART)
- NCT number
- NCT05903040
- Status
- Completed
- Enrollment
- 100 participants, actual
- Lead sponsor
- University of Florence
- Conditions
- Migraine, Migraine With Aura, Migraine Without Aura, Chronic Migraine
- Interventions
- Lasmiditan
- First posted
- 2023-06-15
- Last updated
- 2026-01-21
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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). |
| Primary | Occurrence of treatment-emergent adverse events | 12 weeks | To evaluate the safety and tolerability of Lasmiditan in migraine subjects |
| Secondary | 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). |
| Secondary | 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). |
| Secondary | 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). |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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). |
| Secondary | 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. |
| Secondary | 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) |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers4
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05903040
GET https://conductscience.org/api/trials/v1/NCT05903040/registered