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Trial · NCT05903040

Registered outcomes12

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryHeadache pain freedom at 2 hours post dose during the first attack2 hours post-doseThe 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).
PrimaryOccurrence of treatment-emergent adverse events12 weeksTo evaluate the safety and tolerability of Lasmiditan in migraine subjects
SecondaryHeadache pain freedom at 2 hours post dose across all treated attacks2 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).
SecondaryHeadache pain relief at 2 hours post-dose during the first attack2 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).
SecondaryHeadache pain relief at 2 hours post-dose across all treated attacks2 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).
SecondaryAbility to function normally at 2 hours post-dose during the first attack2 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.
SecondaryAbility to function normally at 2 hours post-dose across all treated attacks2 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.
SecondaryFreedom from the most bothersome symptom (MBS) associated with migraine at 2 hours post-dose during the first attack2 hours post-doseThe 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).
SecondaryHeadache recurrence for the first-attackbetween 2 hours and 24 hours post-dosePercentage of subjects who became pain free at 2 hours post-dose and report new headache pain within 24 hours post-dose.
SecondaryRescue medications use for the first attackbetween 2 hours and 24 hours post dosePercentage 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)
SecondaryTreatment satisfaction2 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).
SecondarySelf-reported treatment effectiveness12 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.

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

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.

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