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

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety and Efficacy of ONZETRA® Xsail® (Sumatriptan Nasal Powder) 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.

Study Overview

• Status: Terminated
• Conditions: Acute Migraine With or Without Aura
• Intervention / Treatment: Drug: sumatriptan nasal powder; Drug: Placebo

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 Type: Interventional
• Enrollment (Actual): 159
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85016
      • Phoenix Children's Hospital
  • California
    • Anaheim, California, United States, 92805
      • Advanced Research Center
    • Los Angeles, California, United States, 90017
      • Axis Clinical Trial Network
    • Los Angeles, California, United States, 90036
      • Axis Clinical Trial Network
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Children's Hospital Colorado
    • Boulder, Colorado, United States, 80301
      • Alpine Clinical Research Center, Inc.
    • Colorado Springs, Colorado, United States, 80907
      • Colorado Springs Neurological Associates
    • Denver, Colorado, United States, 80209
      • Mountain View Clinical Research, Inc.
  • Connecticut
    • Stamford, Connecticut, United States, 06905
      • New England Institute for Neurology and Headache
  • Florida
    • Doral, Florida, United States, 33166
      • International Research Partners, LLC
    • Hialeah, Florida, United States, 33012
      • Direct Helpers Research Center
    • Hialeah, Florida, United States, 33013
      • Eastern Research, Inc.
    • Hialeah, Florida, United States, 33016
      • South Florida Clinical Trials
    • Miami, Florida, United States, 33155
      • Allied Biomedical Research Institute
    • West Palm Beach, Florida, United States, 33407
      • Premiere Research Institute
  • Georgia
    • Atlanta, Georgia, United States, 30328
      • Clinical Integrative Research Center of Atlanta
  • Idaho
    • Meridian, Idaho, United States, 83642
      • St. Luke's Health System
  • Illinois
    • Hoffman Estates, Illinois, United States, 60169
      • AMITA Health Medical Group Pediatric Neurology
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • UK Headache Center Kentucky Neuroscience Institute
  • Michigan
    • Ann Arbor, Michigan, United States, 48104
      • Michigan Head Pain and Neurological Institute
  • Missouri
    • Kansas City, Missouri, United States, 64114
      • Center for Pharmaceutical Research, LLC
    • Springfield, Missouri, United States, 65810
      • Clinvest Research, LLC.
  • Nebraska
    • Hastings, Nebraska, United States, 68901
      • Meridian Clinical Research, LLC
    • Lincoln, Nebraska, United States, 68510
      • Meridian Clinical Research, LLC
  • New Jersey
    • Toms River, New Jersey, United States, 08755
      • Bio Behavioral Health
  • New York
    • Amherst, New York, United States, 14226
      • Dent Neurosciences Research Center
    • Brooklyn, New York, United States, 11201
      • New York Clinical Trials
    • New York, New York, United States, 10022
      • NYCT, A Member of the Alliance, Inc.
  • North Carolina
    • Greensboro, North Carolina, United States, 27405
      • Headache Wellness Center
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Cincinnati Children's Hospital
    • Cincinnati, Ohio, United States, 45215
      • Hometown Urgent Care and Research
    • Dayton, Ohio, United States, 45424
      • Hometown Urgent Care and Research
  • Oklahoma
    • Edmond, Oklahoma, United States, 73034
      • OK Clinical Research, LLC
    • Norman, Oklahoma, United States, 73072
      • Lynn Health Science Institute
    • Oklahoma City, Oklahoma, United States, 73112
      • Lynn Health Science Institute
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15236
      • Preferred Primary Care Physicians, Inc.
  • Texas
    • San Antonio, Texas, United States, 78249
      • Road Runner Research
  • Utah
    • Salt Lake City, Utah, United States, 84117
      • Olympus Family Medicine
    • South Ogden, Utah, United States, 84405
      • South Ogden Family Medicine/CCT Research
  • Washington
    • Bellevue, Washington, United States, 98007
      • Northwest Clinical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 17 years (Child)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sumatriptan nasal powder; Participants will be dosed with 22 milligrams (mg) sumatriptan nasal powder via two nosepieces (11 mg per nosepiece).	Drug: sumatriptan nasal powder; nasal powder administered via nosepiece; Other Names: AVP-825; ONZETRA® Xsail®
Placebo Comparator: Placebo; Participants will be dosed with matching placebo via nosepieces containing capsules filled with lactose instead of sumatriptan.	Drug: Placebo; lactose monohydrate powder administered via nosepiece

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with headache relief at 120 minutes after treatment	Participants will self-report the severity of their headache.	up to 24 weeks
Number of participants who were headache pain free any time after treatment	Participants will self-report the severity of their headache.	up to 24 weeks
Number of participants with headache relief any time after treatment	Participants will self-report the severity of their headache.	up to 24 weeks
Change from Baseline in headache severity any time after treatment	Participants will self-report the severity of their headache. Change from Baseline is defined as the post-Baseline value minus the Baseline value.	Baseline; up to 24 weeks
Number of participants with sustained headache relief	Sustained headache relief is defined as headache relief at 2 hours post-treatment with no worsening of headache, no use of a second dose of study medication, or no use of rescue medication taken through 24 hours after dosing. Participants will self-report the severity of their headache.	up to 24 weeks
Number of participants with sustained pain freedom	Sustained pain freedom is defined as pain freedom at 2 hours post-treatment with no recurrence of headache, no use of a second dose of study medication, or no use of rescue medication taken through 24 hours after dosing. Participants will self-report the severity of their headache.	up to 24 weeks
Number of participants using rescue medication	Participants are allowed to take rescue medication 2 hours after taking the study treatment and after completing the 2- hour post-dose diary questions.	up to 24 weeks
Mean time to rescue medication use	Participants are allowed to take rescue medication 2 hours after taking the study treatment and after completing the 2-hour post-dose diary questions.	up to 24 weeks
Number of participants with nausea, phonophobia, photophobia, or vomiting	Participants will record whether they had migraine symptoms of nausea, phonophobia, photophobia, or vomiting in their diary.	up to 24 weeks
Number of participants who return to "normal" functioning	Participants will record their response to the following question in their diary: "How do you rate your ability to do school-work or perform your usual activities?".	up to 24 weeks
Time to recurrence of headache	Time to recurrence of headache is defined as an increase in headache severity to "moderate" or "severe" within 24 hours. Participants will self-report the severity of their headache.	up to 24 weeks

Collaborators and Investigators

• Sponsor: Currax Pharmaceuticals
• Investigators: Study Chair: Michael Kyle, MD, Currax Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): November 2, 2017
• Primary Completion (Actual): April 11, 2022
• Study Completion (Actual): April 11, 2022

Study Registration Dates

• First Submitted: November 7, 2017
• First Submitted That Met QC Criteria: November 7, 2017
• First Posted (Actual): November 9, 2017

Study Record Updates

• Last Update Posted (Estimated): July 24, 2023
• Last Update Submitted That Met QC Criteria: July 3, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: adolescents; aura; acute migraine; sumatriptan nasal powder; AVP-825
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Serotonin Agents; Serotonin 5-HT1 Receptor Agonists; Serotonin Receptor Agonists; Vasoconstrictor Agents; Sumatriptan
• Other Study ID Numbers: 17-AVP-825-301

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No