Clinical trial NCT03338920: 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
Overall status: TERMINATED
Phase: PHASE3
Conditions: Acute Migraine With or Without Aura
Keywords: acute migraine
aura
sumatriptan nasal powder
AVP-825
adolescents
Lead sponsor: Currax Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2017-11-09
Enrollment: 159
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Primary outcomes:
measure: Number of Participants Who Were Headache Pain Free at 120 Minutes After Treatment
timeFrame: 120 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Phoenix Children's Hospital
state: Arizona
city: Anaheim
country: United States
facility: Advanced Research Center
state: California
city: Los Angeles
country: United States
facility: Axis Clinical Trial Network
state: California
city: Los Angeles
country: United States
facility: Axis Clinical Trial Network
state: California
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
city: Boulder
country: United States
facility: Alpine Clinical Research Center, Inc.
state: Colorado
city: Colorado Springs
country: United States
facility: Colorado Springs Neurological Associates
state: Colorado
city: Denver
country: United States
facility: Mountain View Clinical Research, Inc.
state: Colorado
city: Stamford
country: United States
facility: New England Institute for Neurology and Headache
state: Connecticut
city: Doral
country: United States
facility: International Research Partners, LLC
state: Florida
city: Hialeah
country: United States
facility: Direct Helpers Research Center
state: Florida
city: Hialeah
country: United States
facility: Eastern Research, Inc.
state: Florida
city: Hialeah
country: United States
facility: South Florida Clinical Trials
state: Florida
city: Miami
country: United States
facility: Allied Biomedical Research Institute
state: Florida
city: West Palm Beach
country: United States
facility: Premiere Research Institute
state: Florida
city: Atlanta
country: United States
facility: Clinical Integrative Research Center of Atlanta
state: Georgia
city: Meridian
country: United States
facility: St. Luke's Health System
state: Idaho
city: Hoffman Estates
country: United States
facility: AMITA Health Medical Group Pediatric Neurology
state: Illinois
city: Lexington
country: United States
facility: UK Headache Center Kentucky Neuroscience Institute
state: Kentucky
city: Ann Arbor
country: United States
facility: Michigan Head Pain and Neurological Institute
state: Michigan
city: Kansas City
country: United States
facility: Center for Pharmaceutical Research, LLC
state: Missouri
city: Springfield
country: United States
facility: Clinvest Research, LLC.
state: Missouri
city: Hastings
country: United States
facility: Meridian Clinical Research, LLC
state: Nebraska
city: Lincoln
country: United States
facility: Meridian Clinical Research, LLC
state: Nebraska
city: Toms River
country: United States
facility: Bio Behavioral Health
state: New Jersey
city: Amherst
country: United States
facility: Dent Neurosciences Research Center
state: New York
city: Brooklyn
country: United States
facility: New York Clinical Trials
state: New York
city: New York
country: United States
facility: NYCT, A Member of the Alliance, Inc.
state: New York
city: Greensboro
country: United States
facility: Headache Wellness Center
state: North Carolina
city: Cincinnati
country: United States
facility: Hometown Urgent Care and Research
state: Ohio
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital
state: Ohio
city: Dayton
country: United States
facility: Hometown Urgent Care and Research
state: Ohio
city: Edmond
country: United States
facility: OK Clinical Research, LLC
state: Oklahoma
city: Norman
country: United States
facility: Lynn Health Science Institute
state: Oklahoma
city: Oklahoma City
country: United States
facility: Lynn Health Science Institute
state: Oklahoma
city: Pittsburgh
country: United States
facility: Preferred Primary Care Physicians, Inc.
state: Pennsylvania
city: San Antonio
country: United States
facility: Road Runner Research
state: Texas
city: Salt Lake City
country: United States
facility: Olympus Family Medicine
state: Utah
city: South Ogden
country: United States
facility: South Ogden Family Medicine/CCT Research
state: Utah
city: Bellevue
country: United States
facility: Northwest Clinical Research Center
state: Washington
Study officials:
affiliation: Currax Pharmaceuticals
name: Michael Kyle, MD
role: STUDY_CHAIR
References: