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

July 3, 2023 updated by: Currax Pharmaceuticals

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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
159

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants Who Were Headache Pain Free at 120 Minutes After Treatment
Time Frame: 120 minutes
Participants will self-report the severity of their headache.
120 minutes

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
up to 24 weeks
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.
up to 24 weeks
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.
up to 24 weeks
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.
Baseline; up to 24 weeks
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.
up to 24 weeks
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.
up to 24 weeks
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.
up to 24 weeks
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.
up to 24 weeks
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.
up to 24 weeks
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?".
up to 24 weeks
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.
up to 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Currax Pharmaceuticals

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Michael Kyle, MD, Currax Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 2, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 11, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 11, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 7, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 7, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 9, 2017

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 24, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 3, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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