Acute Migraine With or Without AuraPhase 3NCT03338920
Study to Assess the Safety and Efficacy of ONZETRA® Xsail® for the Acute Treatment of Episodic Migraine With or Without Aura in Adolescents
A Phase 3 study testing sumatriptan nasal powder in people with Acute Migraine With or Without Aura, run by Currax Pharmaceuticals at 40 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Acute Migraine With or Without Aura
- What is being tested?
- sumatriptan nasal powder
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 159 participants
- Where
- 40 sitesUnited States
- Study dates
- 2 Nov 2017to 11 Apr 2022
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
40 sites in 1 country.
40 sites in 1 country
United States40 sites
Dent Neurosciences Research Center
Amherst, New York, 14226
Advanced Research Center
Anaheim, California, 92805
Michigan Head Pain and Neurological Institute
Ann Arbor, Michigan, 48104
Clinical Integrative Research Center of Atlanta
Atlanta, Georgia, 30328
Children's Hospital Colorado
Aurora, Colorado, 80045
Northwest Clinical Research Center
Bellevue, Washington, 98007
Alpine Clinical Research Center, Inc.
Boulder, Colorado, 80301
New York Clinical Trials
Brooklyn, New York, 11201
Hometown Urgent Care and Research
Cincinnati, Ohio, 45215
Cincinnati Children's Hospital
Cincinnati, Ohio, 45229
Colorado Springs Neurological Associates
Colorado Springs, Colorado, 80907
Hometown Urgent Care and Research
Dayton, Ohio, 45424
Mountain View Clinical Research, Inc.
Denver, Colorado, 80209
International Research Partners, LLC
Doral, Florida, 33166
OK Clinical Research, LLC
Edmond, Oklahoma, 73034
Headache Wellness Center
Greensboro, North Carolina, 27405
Meridian Clinical Research, LLC
Hastings, Nebraska, 68901
Direct Helpers Research Center
Hialeah, Florida, 33012
Eastern Research, Inc.
Hialeah, Florida, 33013
South Florida Clinical Trials
Hialeah, Florida, 33016
AMITA Health Medical Group Pediatric Neurology
Hoffman Estates, Illinois, 60169
Center for Pharmaceutical Research, LLC
Kansas City, Missouri, 64114
UK Headache Center Kentucky Neuroscience Institute
Lexington, Kentucky, 40536
Meridian Clinical Research, LLC
Lincoln, Nebraska, 68510
Axis Clinical Trial Network
Los Angeles, California, 90017
Axis Clinical Trial Network
Los Angeles, California, 90036
St. Luke's Health System
Meridian, Idaho, 83642
Allied Biomedical Research Institute
Miami, Florida, 33155
NYCT, A Member of the Alliance, Inc.
New York, New York, 10022
Lynn Health Science Institute
Norman, Oklahoma, 73072
Lynn Health Science Institute
Oklahoma City, Oklahoma, 73112
Phoenix Children's Hospital
Phoenix, Arizona, 85016
Preferred Primary Care Physicians, Inc.
Pittsburgh, Pennsylvania, 15236
Olympus Family Medicine
Salt Lake City, Utah, 84117
Road Runner Research
San Antonio, Texas, 78249
South Ogden Family Medicine/CCT Research
South Ogden, Utah, 84405
Clinvest Research, LLC.
Springfield, Missouri, 65810
New England Institute for Neurology and Headache
Stamford, Connecticut, 06905
Bio Behavioral Health
Toms River, New Jersey, 08755
Premiere Research Institute
West Palm Beach, Florida, 33407
About this study
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
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.
Read the 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).
- Conditions
- Acute Migraine With or Without Aura
- Being tested
- sumatriptan nasal powder, Placebo
- Keywords
- acute migraine, aura, sumatriptan nasal powder, AVP-825, adolescents
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sumatriptan nasal powderDrug
Also called AVP-825, ONZETRA® Xsail®
nasal powder administered via nosepiece
PlaceboDrug
lactose monohydrate powder administered via nosepiece
| Study group | Role | What they receive |
|---|---|---|
| Sumatriptan nasal powder | Experimental | Participants will be dosed with 22 milligrams (mg) sumatriptan nasal powder via two nosepieces (11 mg per nosepiece). Receives: Drug: sumatriptan nasal powder |
| Placebo | Placebo comparator | Participants will be dosed with matching placebo via nosepieces containing capsules filled with lactose instead of sumatriptan. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Were Headache Pain Free at 120 Minutes After Treatment
Participants will self-report the severity of their headache.
Measured: 120 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2017
- Study start2 Nov 2017
- Primary completion11 Apr 2022
- Study completion11 Apr 2022
Why it stopped: eDiary data collected not sufficient to utilize in the analysis of protocol endpoints
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Acute Migraine With or Without AuraStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- Currax Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Kyle, MD, Study chair, Currax Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03338920
- Sponsor's protocol ID
- 17-AVP-825-301
- Status last verified
- Jun 2023
- First submitted
- 7 Nov 2017
- Last updated
- 24 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03338920
- Acronym / sponsor ID
- 17-AVP-825-301
- Conditions
- Acute Migraine With or Without Aura
- Keywords
- acute migraine, aura, sumatriptan nasal powder, AVP-825, adolescents
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: eDiary data collected not sufficient to utilize in the analysis of protocol endpoints
- Enrolment
- 159 participants (actual)
- Lead sponsor
- Currax PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 2 Nov 2017 (actual)
- Primary completion
- 11 Apr 2022 (actual)
- Study completion
- 11 Apr 2022 (actual)
- First posted
- 9 Nov 2017 (actual)
- Results
- Posted 24 Jul 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sumatriptan nasal powder | Experimental | Drug: sumatriptan nasal powderParticipants will be dosed with 22 milligrams (mg) sumatriptan nasal powder via two nosepieces (11 mg per nosepiece). |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will be dosed with matching placebo via nosepieces containing capsules filled with lactose instead of sumatriptan. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sumatriptan nasal powderAlso: AVP-825, ONZETRA® Xsail®nasal powder administered via nosepiece | Drug | Sumatriptan nasal powder |
| Placebolactose monohydrate powder administered via nosepiece | Drug | Placebo |
Primary outcome
Number of Participants Who Were Headache Pain Free at 120 Minutes After Treatment
Time frame: 120 minutes
Participants will self-report the severity of their headache.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Kyle, MD study chair
Currax Pharmaceuticals
40 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing sumatriptan nasal powder in people with Acute Migraine With or Without Aura, run by Currax Pharmaceuticals at 40 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 40 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Jul 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who Were Headache Pain Free at 120 Minutes After Treatment (time frame: 120 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2023.