Hialeah, Florida 33012

  • Acute Migraine With or Without Aura

Purpose:

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.


Study summary:

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).


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.


NCT ID:

NCT03338920


Primary Contact:

Study Chair
Errol Gould, PhD
Currax Pharmaceuticals

Natalie Pummill
Phone: 973.774.1164
Email: natalie.pummill@ecrscorp.com


Backup Contact:

Email: felix.yip@ecrscorp.com
Felix Yip
Phone: 905.752.2610


Location Contact:

Hialeah, Florida 33012
United States



There is no listed contact information for this specific location.

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: September 23, 2021

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