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

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Acute Migraine With or Without Aura

In brief

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.

Key facts

Study ID

NCT03338920

Run by

Currax Pharmaceuticals

People needed

159

Starts

2017-11-02

Expected to finish

2022-04-11

Last updated by the study team

2023-07-24

Who can join

Age: 12 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Phoenix Children's Hospital — Phoenix, Arizona, United States
• Advanced Research Center — Anaheim, California, United States
• Axis Clinical Trial Network — Los Angeles, California, United States
• Axis Clinical Trial Network — Los Angeles, California, United States
• Children's Hospital Colorado — Aurora, Colorado, United States
• Alpine Clinical Research Center, Inc. — Boulder, Colorado, United States
• Colorado Springs Neurological Associates — Colorado Springs, Colorado, United States
• Mountain View Clinical Research, Inc. — Denver, Colorado, United States
• New England Institute for Neurology and Headache — Stamford, Connecticut, United States
• International Research Partners, LLC — Doral, Florida, United States
• Direct Helpers Research Center — Hialeah, Florida, United States
• Eastern Research, Inc. — Hialeah, Florida, United States
• South Florida Clinical Trials — Hialeah, Florida, United States
• Allied Biomedical Research Institute — Miami, Florida, United States
• Premiere Research Institute — West Palm Beach, Florida, United States
• Clinical Integrative Research Center of Atlanta — Atlanta, Georgia, United States
• St. Luke's Health System — Meridian, Idaho, United States
• AMITA Health Medical Group Pediatric Neurology — Hoffman Estates, Illinois, United States
• UK Headache Center Kentucky Neuroscience Institute — Lexington, Kentucky, United States
• Michigan Head Pain and Neurological Institute — Ann Arbor, Michigan, United States
• Center for Pharmaceutical Research, LLC — Kansas City, Missouri, United States
• Clinvest Research, LLC. — Springfield, Missouri, United States
• Meridian Clinical Research, LLC — Hastings, Nebraska, United States
• Meridian Clinical Research, LLC — Lincoln, Nebraska, United States
• Bio Behavioral Health — Toms River, New Jersey, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.