An Efficacy and Safety Study of DFN-02 (Sumatriptan Nasal Spray 10 mg)
Condition: Migraine Headaches
MeSH terms: Migraine Disorders; Headache
Study type: Interventional
Phase: Phase 2

Summary: 
      A safety and efficacy study of DFN-02 (Sumatriptan Nasal Spray 10 mg), being conducted at
      multiple centers in the United States.
    

Detailed description: 
      This was a randomized, two double-blind (DB) treatment period dosing study.

      Previously diagnosed subjects with a history of episodic migraine (as defined by
      International Classification of Headache Disorders (ICHD), 3rd edition [beta version] [ICHD
      3]) who experienced an average of 2 to 8 migraine attacks per month for at least the prior 12
      months, with no more than 14 headache days per month, and with 48 hours of headache free time
      between migraine, were randomized in a 1:1 ratio in both DB periods to receive either DFN-02
      (sumatriptan nasal spray 10 mg) or a matching placebo.

      Subjects treated one moderate to severe migraine attack in the first double-blind treatment
      period (DB1) and, if eligible, were re-randomized into the second double-blind treatment
      period (DB2) to treat another migraine attack at any pain level.

      There was a screening period of up to 21 days to evaluate whether subjects fit the migraine
      inclusion criteria pursuant to ICHD-3, and did not have medication overuse. Subjects with at
      least a 12 month medical history of acute migraine were eligible for enrollment in the
      treatment period. Subjects continued to take their normal migraine medication during this
      screening period.

      If eligible and randomized, subjects in the DB1 treatment period were instructed to use the
      study medication in one migraine attack as soon as (and no more than within one hour after)
      experiencing moderate to severe migraine pain (defined as headache pain rating of Grade 2
      [moderate] or Grade 3 [severe] on a pain severity scale of 0 to 3). If the subject was not
      able to use study medication for the first migraine after randomization, they were instructed
      to use the study medication for the next attack. Those subjects who did not experience a
      migraine attack, and/or did not treat any migraine attack with study medication or record
      diary data, were not allowed to continue into the DB2 treatment period, and were
      discontinued.

      After treating a migraine attack with study medication, subjects were instructed to contact
      the site within 24 hours of the treated migraine (or the next working day) to schedule their
      next visit.

      Subjects returned to the study site within 2 to 7 days in the DB1 treatment period and, if
      continuing to be eligible, were re-randomized into a DB2 treatment period to treat one
      migraine attack at any pain level, and return to the study site within 2 to 7 days of the
      second treatment.

      Once randomized, the total duration of each subject's participation in the study was up to 10
      weeks.
    

Intervention name(s): Sumatriptan 10 mg Nasal Spray; Sumatriptan Placebo Nasal Spray
Intervention type(s): Drug; Other
Intervention description(s): 100 μL nasal spray once; 100 μL nasal spray once
Other intervention name(s): Sumatriptan
Intervention MeSH terms: Sumatriptan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Aura