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Trial · NCT02439320

Registered outcomes12

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

ListOutcomeTime frameDescription
PrimaryPercentage of Participants Who Are Headache Pain Free2 hours post doseThe percentage of participants defined as mild, moderate, or severe headache pain becoming none.
PrimaryPercentage of Participants Who Are Most Bothersome Symptom (MBS) Free2 hours post doseThe percentage of participants defined as the associated symptom present and identified as MBS (nausea, photophobia, or phonophobia) prior to dosing being absent.
SecondaryPercentage of Participants Who Have Headache Relief After First Dose2 hours post doseThe percentage of participants with headache pain moderate or severe which became mild or none or with headache pain mild which became none.
SecondaryPercentage of Participants With Headache RecurrenceFrom 2 hours post dose up to 48 hoursParticipants who received study drug and which became pain free at 2 hours post-dose and worsened again up to 48 hours post-dose.
SecondaryPercentage of Participants Who Used Rescue Medication2 hours post doseRescue medication was permitted after completion of the 2 hour assessment if the migraine did not respond (participant was not pain free).
SecondaryPercentage of Participants Who Used Rescue MedicationAnytime between 2-24 hours post doseRescue medication was permitted after completion of the 2 hour assessment if the migraine did not respond (participant was not pain free).
SecondaryPercentage of Participants Who Used Rescue MedicationAnytime 24-48 hours post doseRescue medication was permitted after completion of the 2 hour assessment if the migraine did not respond (participant was not pain free).
SecondaryPercentage of Participants Nausea Free2 hours post doseThe percentage of participants without nausea.
SecondaryPercentage of Participants Phonophobia Free2 hours post doseThe percentage of participants without phonophobia.
SecondaryPercentage of Participants Photophobia Free2 hours post doseThe percentage of participants without photophobia.
SecondaryParticipants With Serious Adverse Events (SAE)Baseline up to 11 weeks
Safety and Tolerability was assessed by the number of participants with at least 1 treatment emergent event (TEAE). A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section
OtherPercentage of Participants With Resource Utilization6 months prior to enrolling in study to end of study (Up to 11 Weeks) within 7 days of treating a single migraine attackUse of health care for treatment 6 months prior to enrolling in the study and information reported during time on study

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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