Study to Assess the Safety and Efficacy of ONZETRA® Xsail® for the Acute Treatment of Episodic Migraine With or Without Aura in Adolescents
Study to Assess the Safety and Efficacy of ONZETRA® Xsail® for the Acute Treatment of Episodic Migraine With or Without Aura in Adolescents
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.
This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study evaluating
 AVP-825 for the acute treatment of migraine with or without aura in adolescent subjects (12
 to 17 years old).
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.