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

NCT03338920 | Terminated Phase 3 Results FDA Drug

• 1 other identifier: 17-AVP-825-301
• Study Type: interventional
• Target: 159
• Locations: 1 country
• Sites: 40

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.

Conditions

Acute Migraine With or Without Aura

Keywords

acute migraine; aura; sumatriptan nasal powder; AVP-825; adolescents

Outcome Measures

Primary Outcomes (1)

• Number of Participants Who Were Headache Pain Free at 120 Minutes After Treatment

  Participants will self-report the severity of their headache.

  120 minutes

Study Arms (2)

Sumatriptan nasal powder

EXPERIMENTAL

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

Drug: sumatriptan nasal powder

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

sumatriptan nasal powder DRUG

nasal powder administered via nosepiece

Also known as: AVP-825, ONZETRA® Xsail®

Sumatriptan nasal powder

Placebo DRUG

lactose monohydrate powder administered via nosepiece

Placebo

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Currax Pharmaceuticals: lead

Study Sites (40)

Phoenix Children's Hospital

Phoenix, Arizona, 85016, United States

Location

Advanced Research Center

Anaheim, California, 92805, United States

Location

Axis Clinical Trial Network

Los Angeles, California, 90017, United States

Location

Axis Clinical Trial Network

Los Angeles, California, 90036, United States

Location

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location

Alpine Clinical Research Center, Inc.

Boulder, Colorado, 80301, United States

Location

Colorado Springs Neurological Associates

Colorado Springs, Colorado, 80907, United States

Location

Mountain View Clinical Research, Inc.

Denver, Colorado, 80209, United States

Location

New England Institute for Neurology and Headache

Stamford, Connecticut, 06905, United States

Location

International Research Partners, LLC

Doral, Florida, 33166, United States

Location

Direct Helpers Research Center

Hialeah, Florida, 33012, United States

Location

Eastern Research, Inc.

Hialeah, Florida, 33013, United States

Location

South Florida Clinical Trials

Hialeah, Florida, 33016, United States

Location

Allied Biomedical Research Institute

Miami, Florida, 33155, United States

Location

Premiere Research Institute

West Palm Beach, Florida, 33407, United States

Location

Clinical Integrative Research Center of Atlanta

Atlanta, Georgia, 30328, United States

Location

St. Luke's Health System

Meridian, Idaho, 83642, United States

Location

AMITA Health Medical Group Pediatric Neurology

Hoffman Estates, Illinois, 60169, United States

Location

UK Headache Center Kentucky Neuroscience Institute

Lexington, Kentucky, 40536, United States

Location

Michigan Head Pain and Neurological Institute

Ann Arbor, Michigan, 48104, United States

Location

Center for Pharmaceutical Research, LLC

Kansas City, Missouri, 64114, United States

Location

Clinvest Research, LLC.

Springfield, Missouri, 65810, United States

Location

Meridian Clinical Research, LLC

Hastings, Nebraska, 68901, United States

Location

Meridian Clinical Research, LLC

Lincoln, Nebraska, 68510, United States

Location

Bio Behavioral Health

Toms River, New Jersey, 08755, United States

Location

Dent Neurosciences Research Center

Amherst, New York, 14226, United States

Location

New York Clinical Trials

Brooklyn, New York, 11201, United States

Location

NYCT, A Member of the Alliance, Inc.

New York, New York, 10022, United States

Location

Headache Wellness Center

Greensboro, North Carolina, 27405, United States

Location

Hometown Urgent Care and Research

Cincinnati, Ohio, 45215, United States

Location

Cincinnati Children's Hospital

Cincinnati, Ohio, 45229, United States

Location

Hometown Urgent Care and Research

Dayton, Ohio, 45424, United States

Location

OK Clinical Research, LLC

Edmond, Oklahoma, 73034, United States

Location

Lynn Health Science Institute

Norman, Oklahoma, 73072, United States

Location

Lynn Health Science Institute

Oklahoma City, Oklahoma, 73112, United States

Location

Preferred Primary Care Physicians, Inc.

Pittsburgh, Pennsylvania, 15236, United States

Location

Road Runner Research

San Antonio, Texas, 78249, United States

Location

Olympus Family Medicine

Salt Lake City, Utah, 84117, United States

Location

South Ogden Family Medicine/CCT Research

South Ogden, Utah, 84405, United States

Location

Northwest Clinical Research Center

Bellevue, Washington, 98007, United States

Location

MeSH Terms

Conditions

Epilepsy

Interventions

Sumatriptan

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Michael Kyle
• Organization: Currax Pharmaceuticals LLC

mkyle@curraxpharma.com

708.834.8254

Study Officials

• Michael Kyle, MD

  Currax Pharmaceuticals

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2017
• First Posted: November 9, 2017
• Study Start: November 2, 2017
• Primary Completion: April 11, 2022
• Study Completion: April 11, 2022
• Last Updated: July 24, 2023
• Results First Posted: July 24, 2023

Record last verified: 2023-06

Locations

US (40)