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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 is currently recruiting participants.
Verified November 2017 by Avanir Pharmaceuticals
Sponsor:
ClinicalTrials.gov Identifier:
NCT03338920
First Posted: November 9, 2017
Last Update Posted: November 9, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Avanir Pharmaceuticals
  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.

Condition Intervention Phase
Acute Migraine With or Without Aura Drug: sumatriptan nasal powder Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Avanir Pharmaceuticals:

Primary Outcome Measures:
  • Number of participants who were headache pain free at 120 minutes after treatment [ Time Frame: up to 24 weeks ]
    Participants will self-report the severity of their headache.


Secondary Outcome Measures:
  • Number of participants with headache relief at 120 minutes after treatment [ Time Frame: up to 24 weeks ]
    Participants will self-report the severity of their headache.

  • Number of participants who were headache pain free any time after treatment [ Time Frame: up to 24 weeks ]
    Participants will self-report the severity of their headache.

  • Number of participants with headache relief any time after treatment [ Time Frame: up to 24 weeks ]
    Participants will self-report the severity of their headache.

  • Change from Baseline in headache severity any time after treatment [ Time Frame: Baseline; up to 24 weeks ]
    Participants will self-report the severity of their headache. Change from Baseline is defined as the post-Baseline value minus the Baseline value.

  • Number of participants with sustained headache relief [ Time Frame: up to 24 weeks ]
    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.

  • Number of participants with sustained pain freedom [ Time Frame: up to 24 weeks ]
    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.

  • Number of participants using rescue medication [ Time Frame: up to 24 weeks ]
    Participants are allowed to take rescue medication 2 hours after taking the study treatment and after completing the 2- hour post-dose diary questions.

  • Mean time to rescue medication use [ Time Frame: up to 24 weeks ]
    Participants are allowed to take rescue medication 2 hours after taking the study treatment and after completing the 2-hour post-dose diary questions.

  • Number of participants with nausea, phonophobia, photophobia, or vomiting [ Time Frame: up to 24 weeks ]
    Participants will record whether they had migraine symptoms of nausea, phonophobia, photophobia, or vomiting in their diary.

  • Number of participants who return to "normal" functioning [ Time Frame: up to 24 weeks ]
    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?".

  • Time to recurrence of headache [ Time Frame: up to 24 weeks ]
    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.


Estimated Enrollment: 420
Actual Study Start Date: November 2, 2017
Estimated Study Completion Date: November 2019
Estimated Primary Completion Date: November 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03338920


Contacts
Contact: Marco Armijo 949-238-4075 marmijo@avanir.com
Contact: Nadine Knowles 949-268-8972 nknowles@avanir.com

Locations
United States, California
Fullerton Neurology and Headache Center Recruiting
Fullerton, California, United States, 92835
United States, Connecticut
Associated Neurologists of Southern CT, P.C. Recruiting
Fairfield, Connecticut, United States, 06824
United States, Florida
Premiere Research Institute Recruiting
West Palm Beach, Florida, United States, 33407
United States, Massachusetts
New England Regional Headache Center, Inc Recruiting
Worcester, Massachusetts, United States, 01605
United States, Michigan
Michigan Head Pain and Neurological Institute Recruiting
Ann Arbor, Michigan, United States, 48104
United States, Missouri
Clinvest Research, LLC. Recruiting
Springfield, Missouri, United States, 65810
United States, Pennsylvania
Preferred Primary Care Physicians, Inc. Recruiting
Pittsburgh, Pennsylvania, United States, 15236
United States, Washington
Northwest Clinical Research Center Recruiting
Bellevue, Washington, United States, 98007
Sponsors and Collaborators
Avanir Pharmaceuticals
Investigators
Study Chair: Doina Cosma-Roman, MD Avanir Pharmaceuticals
  More Information

Responsible Party: Avanir Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03338920     History of Changes
Other Study ID Numbers: 17-AVP-825-301
First Submitted: November 7, 2017
First Posted: November 9, 2017
Last Update Posted: November 9, 2017
Last Verified: November 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Avanir Pharmaceuticals:
acute migraine
aura
sumatriptan nasal powder
AVP-825
adolescents

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Sumatriptan
Vasoconstrictor Agents
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs