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

Primary Purpose

Acute Migraine With or Without Aura

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
sumatriptan nasal powder
Placebo
Sponsored by
Currax Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Migraine With or Without Aura focused on measuring acute migraine, aura, sumatriptan nasal powder, AVP-825, adolescents

Eligibility Criteria

12 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Phoenix Children's Hospital
  • Advanced Research Center
  • Axis Clinical Trial Network
  • Axis Clinical Trial Network
  • Children's Hospital Colorado
  • Alpine Clinical Research Center, Inc.
  • Colorado Springs Neurological Associates
  • Mountain View Clinical Research, Inc.
  • New England Institute for Neurology and Headache
  • International Research Partners, LLC
  • Direct Helpers Research Center
  • Eastern Research, Inc.
  • South Florida Clinical Trials
  • Allied Biomedical Research Institute
  • Premiere Research Institute
  • Clinical Integrative Research Center of Atlanta
  • St. Luke's Health System
  • AMITA Health Medical Group Pediatric Neurology
  • UK Headache Center Kentucky Neuroscience Institute
  • Michigan Head Pain and Neurological Institute
  • Center for Pharmaceutical Research, LLC
  • Clinvest Research, LLC.
  • Meridian Clinical Research, LLC
  • Meridian Clinical Research, LLC
  • Bio Behavioral Health
  • Dent Neurosciences Research Center
  • New York Clinical Trials
  • NYCT, A Member of the Alliance, Inc.
  • Headache Wellness Center
  • Hometown Urgent Care and Research
  • Cincinnati Children's Hospital
  • Hometown Urgent Care and Research
  • OK Clinical Research, LLC
  • Lynn Health Science Institute
  • Lynn Health Science Institute
  • Preferred Primary Care Physicians, Inc.
  • Road Runner Research
  • Olympus Family Medicine
  • South Ogden Family Medicine/CCT Research
  • Northwest Clinical Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Sumatriptan nasal powder

Placebo

Arm Description

Participants will be dosed with 22 milligrams (mg) sumatriptan nasal powder via two nosepieces (11 mg per nosepiece).

Participants will be dosed with matching placebo via nosepieces containing capsules filled with lactose instead of sumatriptan.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
November 7, 2017
Last Updated
July 3, 2023
Sponsor
Currax Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT03338920
Brief Title
Study to Assess the Safety and Efficacy of ONZETRA® Xsail® for the Acute Treatment of Episodic Migraine With or Without Aura in Adolescents
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Terminated
Why Stopped
eDiary data collected not sufficient to utilize in the analysis of protocol endpoints
Study Start Date
November 2, 2017 (Actual)
Primary Completion Date
April 11, 2022 (Actual)
Study Completion Date
April 11, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Currax Pharmaceuticals

4. Oversight

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

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Migraine With or Without Aura
Keywords
acute migraine, aura, sumatriptan nasal powder, AVP-825, adolescents

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
159 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sumatriptan nasal powder
Arm Type
Experimental
Arm Description
Participants will be dosed with 22 milligrams (mg) sumatriptan nasal powder via two nosepieces (11 mg per nosepiece).
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will be dosed with matching placebo via nosepieces containing capsules filled with lactose instead of sumatriptan.
Intervention Type
Drug
Intervention Name(s)
sumatriptan nasal powder
Other Intervention Name(s)
AVP-825, ONZETRA® Xsail®
Intervention Description
nasal powder administered via nosepiece
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
lactose monohydrate powder administered via nosepiece
Primary Outcome Measure Information:
Title
Number of Participants Who Were Headache Pain Free at 120 Minutes After Treatment
Description
Participants will self-report the severity of their headache.
Time Frame
120 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Kyle, MD
Organizational Affiliation
Currax Pharmaceuticals
Official's Role
Study Chair
Facility Information:
Facility Name
Phoenix Children's Hospital
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Facility Name
Advanced Research Center
City
Anaheim
State/Province
California
ZIP/Postal Code
92805
Country
United States
Facility Name
Axis Clinical Trial Network
City
Los Angeles
State/Province
California
ZIP/Postal Code
90017
Country
United States
Facility Name
Axis Clinical Trial Network
City
Los Angeles
State/Province
California
ZIP/Postal Code
90036
Country
United States
Facility Name
Children's Hospital Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Alpine Clinical Research Center, Inc.
City
Boulder
State/Province
Colorado
ZIP/Postal Code
80301
Country
United States
Facility Name
Colorado Springs Neurological Associates
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Facility Name
Mountain View Clinical Research, Inc.
City
Denver
State/Province
Colorado
ZIP/Postal Code
80209
Country
United States
Facility Name
New England Institute for Neurology and Headache
City
Stamford
State/Province
Connecticut
ZIP/Postal Code
06905
Country
United States
Facility Name
International Research Partners, LLC
City
Doral
State/Province
Florida
ZIP/Postal Code
33166
Country
United States
Facility Name
Direct Helpers Research Center
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Facility Name
Eastern Research, Inc.
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33013
Country
United States
Facility Name
South Florida Clinical Trials
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
Allied Biomedical Research Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Facility Name
Premiere Research Institute
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
Facility Name
Clinical Integrative Research Center of Atlanta
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
St. Luke's Health System
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
Facility Name
AMITA Health Medical Group Pediatric Neurology
City
Hoffman Estates
State/Province
Illinois
ZIP/Postal Code
60169
Country
United States
Facility Name
UK Headache Center Kentucky Neuroscience Institute
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
Michigan Head Pain and Neurological Institute
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48104
Country
United States
Facility Name
Center for Pharmaceutical Research, LLC
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64114
Country
United States
Facility Name
Clinvest Research, LLC.
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65810
Country
United States
Facility Name
Meridian Clinical Research, LLC
City
Hastings
State/Province
Nebraska
ZIP/Postal Code
68901
Country
United States
Facility Name
Meridian Clinical Research, LLC
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68510
Country
United States
Facility Name
Bio Behavioral Health
City
Toms River
State/Province
New Jersey
ZIP/Postal Code
08755
Country
United States
Facility Name
Dent Neurosciences Research Center
City
Amherst
State/Province
New York
ZIP/Postal Code
14226
Country
United States
Facility Name
New York Clinical Trials
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11201
Country
United States
Facility Name
NYCT, A Member of the Alliance, Inc.
City
New York
State/Province
New York
ZIP/Postal Code
10022
Country
United States
Facility Name
Headache Wellness Center
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27405
Country
United States
Facility Name
Hometown Urgent Care and Research
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45215
Country
United States
Facility Name
Cincinnati Children's Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Facility Name
Hometown Urgent Care and Research
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45424
Country
United States
Facility Name
OK Clinical Research, LLC
City
Edmond
State/Province
Oklahoma
ZIP/Postal Code
73034
Country
United States
Facility Name
Lynn Health Science Institute
City
Norman
State/Province
Oklahoma
ZIP/Postal Code
73072
Country
United States
Facility Name
Lynn Health Science Institute
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Preferred Primary Care Physicians, Inc.
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15236
Country
United States
Facility Name
Road Runner Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78249
Country
United States
Facility Name
Olympus Family Medicine
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84117
Country
United States
Facility Name
South Ogden Family Medicine/CCT Research
City
South Ogden
State/Province
Utah
ZIP/Postal Code
84405
Country
United States
Facility Name
Northwest Clinical Research Center
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98007
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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