Acute Migraine With or Without Aura Clinical Trial
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
| Verified date | June 2023 |
| Source | Currax Pharmaceuticals |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Terminated |
| Enrollment | 159 |
| Est. completion date | April 11, 2022 |
| Est. primary completion date | April 11, 2022 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 12 Years to 17 Years |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Dent Neurosciences Research Center | Amherst | New York |
| United States | Advanced Research Center | Anaheim | California |
| United States | Michigan Head Pain and Neurological Institute | Ann Arbor | Michigan |
| United States | Clinical Integrative Research Center of Atlanta | Atlanta | Georgia |
| United States | Children's Hospital Colorado | Aurora | Colorado |
| United States | Northwest Clinical Research Center | Bellevue | Washington |
| United States | Alpine Clinical Research Center, Inc. | Boulder | Colorado |
| United States | New York Clinical Trials | Brooklyn | New York |
| United States | Cincinnati Children's Hospital | Cincinnati | Ohio |
| United States | Hometown Urgent Care and Research | Cincinnati | Ohio |
| United States | Colorado Springs Neurological Associates | Colorado Springs | Colorado |
| United States | Hometown Urgent Care and Research | Dayton | Ohio |
| United States | Mountain View Clinical Research, Inc. | Denver | Colorado |
| United States | International Research Partners, LLC | Doral | Florida |
| United States | OK Clinical Research, LLC | Edmond | Oklahoma |
| United States | Headache Wellness Center | Greensboro | North Carolina |
| United States | Meridian Clinical Research, LLC | Hastings | Nebraska |
| 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 | AMITA Health Medical Group Pediatric Neurology | Hoffman Estates | Illinois |
| United States | Center for Pharmaceutical Research, LLC | Kansas City | Missouri |
| United States | UK Headache Center Kentucky Neuroscience Institute | Lexington | Kentucky |
| United States | Meridian Clinical Research, LLC | Lincoln | Nebraska |
| United States | Axis Clinical Trial Network | Los Angeles | California |
| United States | Axis Clinical Trial Network | Los Angeles | California |
| United States | St. Luke's Health System | Meridian | Idaho |
| United States | Allied Biomedical Research Institute | Miami | Florida |
| United States | NYCT, A Member of the Alliance, Inc. | New York | New York |
| United States | Lynn Health Science Institute | Norman | Oklahoma |
| United States | Lynn Health Science Institute | Oklahoma City | Oklahoma |
| United States | Phoenix Children's Hospital | Phoenix | Arizona |
| United States | Preferred Primary Care Physicians, Inc. | Pittsburgh | Pennsylvania |
| United States | Olympus Family Medicine | Salt Lake City | Utah |
| United States | Road Runner Research | San Antonio | Texas |
| United States | South Ogden Family Medicine/CCT Research | South Ogden | Utah |
| United States | Clinvest Research, LLC. | Springfield | Missouri |
| United States | New England Institute for Neurology and Headache | Stamford | Connecticut |
| United States | Bio Behavioral Health | Toms River | New Jersey |
| United States | Premiere Research Institute | West Palm Beach | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| Currax Pharmaceuticals |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of Participants Who Were Headache Pain Free at 120 Minutes After Treatment | Participants will self-report the severity of their headache. | 120 minutes |