Study to Assess the Safety and Efficacy of ONZETRA® Xsail® for the Acute Treatment of Episodic Migraine With or Without Aura in Adolescents
Condition: Acute Migraine With or Without Aura
MeSH terms: Migraine Disorders
Intervention: sumatriptan nasal powder; Placebo
Intervention description: nasal powder administered via nosepiece; lactose monohydrate powder administered via nosepiece
Intervention MeSH terms: Sumatriptan
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 159.0
Sex: All
Minimum age: 12 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: acute migraine; aura; sumatriptan nasal powder; AVP-825; adolescents

Summary:

      This study will be conducted to evaluate the safety and efficacy of sumatriptan nasal powder
      (AVP-825) compared to placebo in the acute treatment of migraine in adolescent participants,
      12 through 17 years of age.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female participants 12 to 17 years (inclusive) of age at the time of informed
             consent

          -  Have a diagnosis of episodic migraine with or without aura according to International
             Classification of Headache Disorders-Third edition, beta version (ICHD-IIIB, 1.2.1 or
             1.1) criteria, for at least 1 year prior to the screening/enrollment visit

          -  Experienced migraine attacks of moderate-to-severe intensity and typically lasting ≥ 3
             hours untreated, occurring at a frequency of ≥ 2 to ≤ 14 attacks per month for the
             past 6 months prior to the screening/enrollment visit

          -  Participant's parent or legal guardian must be willing to sign a copy of the informed
             consent form as well as documentation for Written Authorization for Use and Release of
             Health and Research Study Information, after the nature and risks of study
             participation have been fully explained. Participants must be willing to provide
             informed assent.

        Exclusion Criteria:

          -  Participants with ≥ 15 headache days per month in total (migraine, probable migraine,
             or tension-type)

          -  Participants with the following headache types: retinal (ICHD-IIIB, 1.2.4), with
             brainstem aura (ICHD-IIIB, 1.2.2), hemiplegic (ICHD-IIIB, 1.2.3), status migrainosus
             (ICHD-IIIB, 1.4.1), other forms of complicated migraine, or secondary headaches

          -  Participants who have not responded to an adequate dose and appropriate duration of
             treatment with 2 or more triptans

          -  Participants with known nasal obstruction, current uncontrolled nasopharyngeal
             illness, or known velum insufficiency (i.e., a cleft palate and/or structural
             abnormalities in the soft palate and nasopharynx) that may interfere with the proper
             use of study medication

          -  Participants whose conditions in the investigator's opinion may put the participant at
             significant safety risk or confound the study results. This includes participants who
             in the investigator's opinion should not be enrolled in the study due to the risks
             described in the Warnings and Precautions or Contraindications sections of the ONZETRA
             Xsail Prescribing Information.