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



Status:Recruiting
Conditions:Migraine Headaches
Therapuetic Areas:Neurology
Healthy:No
Age Range:12 - 17
Updated:3/9/2019
Start Date:November 2, 2017
End Date:November 2019
Contact:Fred Ledon
Email:fledon@avanir.com
Phone:949-389-6724

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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.


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.
We found this trial at
41
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1000 Alpine
Boulder, Colorado 80304
303-443-7229
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5673 Ptree Dun Rd NE # 440
Atlanta, Georgia 30342
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13123 E 16th Ave
Aurora, Colorado 80045
(720) 777-1234
Children's Hospital Colorado At Children's Hospital Colorado, we see more, treat more and heal more...
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Bellevue, Washington 98007
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Charlottesville, Virginia 22901
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Chula Vista, California 91911
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10575 Springfield Pike
Cincinnati, Ohio 45215
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Colorado Springs, Colorado 80907
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Denver, Colorado 80209
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120 North Bryant Avenue
Edmond, Oklahoma 73034
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Fairfield, Connecticut 06824
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Frisco, Texas 75034
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Frisco, Texas 75035
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Fullerton, California 92835
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Hialeah, Florida 33013
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1555 North Barrington Road
Hoffman Estates, Illinois 60169
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Kansas City, Missouri 64114
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Las Vegas, Nevada 89106
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Louisville, Kentucky 40207
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Meridian, Idaho 83642
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Minneapolis, Minnesota 55402
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545 8th Avenue
New York, New York 10022
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3555 NW 58th St # 800
Oklahoma City, Oklahoma 73112
(405) 447-8839
Lynn Health Science Institute Our mission is to provide clinical trials research and health services...
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1919 E Thomas Rd
Phoenix, Arizona 85006
(602) 933-1000
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Pittsburgh, Pennsylvania 15243
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Plymouth, Minnesota 55441
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San Antonio, Texas 78258
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Springfield, Missouri 65807
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Toms River, New Jersey 08755
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West Palm Beach, Florida 33407
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Worcester, Massachusetts 01605
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