Study to Assess the Safety and Efficacy of ONZETRA® Xsail® for the Acute Treatment of Episodic Migraine With or Without Aura in Adolescents

Phase 3

Terminated

• Conditions: Acute Migraine With or Without Aura
• Interventions: Drug: sumatriptan nasal powder; Drug: Placebo

• Registration Number: NCT03338920
• Lead Sponsor: Currax Pharmaceuticals

Brief 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.

Detailed Description

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).

Study Timeline

• Study Start: 2017-11-02
• Study First Submitted: 2017-11-07
• Study First Submitted QC: 2017-11-07
• Study First Posted: 2017-11-09
• Primary Completion: 2022-04-11
• Study Completion: 2022-04-11
• Status Verified: 2023-06
• Results First Submitted: 2023-06-13
• Results First Submitted QC: 2023-07-03
• Last Update Submitted: 2023-07-03
• Results First Posted: 2023-07-24
• Last Update Posted: 2023-07-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 159

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sumatriptan nasal powder	sumatriptan nasal powder	Participants will be dosed with 22 milligrams (mg) sumatriptan nasal powder via two nosepieces (11 mg per nosepiece).
Placebo	Placebo	Participants will be dosed with matching placebo via nosepieces containing capsules filled with lactose instead of sumatriptan.

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Were Headache Pain Free at 120 Minutes After Treatment	120 minutes	Participants will self-report the severity of their headache.

Trial Locations

Locations (36)

Phoenix Children's Hospital; 🇺🇸 Phoenix, Arizona, United States

Advanced Research Center; 🇺🇸 Anaheim, California, United States

Axis Clinical Trial Network; 🇺🇸 Los Angeles, California, United States

Children's Hospital Colorado; 🇺🇸 Aurora, Colorado, United States

Alpine Clinical Research Center, Inc.; 🇺🇸 Boulder, Colorado, United States

Colorado Springs Neurological Associates; 🇺🇸 Colorado Springs, Colorado, United States

Mountain View Clinical Research, Inc.; 🇺🇸 Denver, Colorado, United States

New England Institute for Neurology and Headache; 🇺🇸 Stamford, Connecticut, United States

International Research Partners, LLC; 🇺🇸 Doral, Florida, United States

Direct Helpers Research Center; 🇺🇸 Hialeah, Florida, United States

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