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
NCT03338920, Phase 3, Terminated, Currax Pharmaceuticals; results first posted 2023-07-24
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study to Assess the Safety and Efficacy of ONZETRA® Xsail® for the Acute Treatment of Episodic Migraine With or Without Aura in Adolescents. Trials, record NCT03338920. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03338920
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Assess the Safety and Efficacy of ONZETRA® Xsail® for the Acute Treatment of Episodic Migraine With or Without Aura in Adolescents
- NCT number
- NCT03338920
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 159 participants, actual
- Lead sponsor
- Currax Pharmaceuticals
- Conditions
- Acute Migraine With or Without Aura
- Interventions
- sumatriptan nasal powder, Placebo
- First posted
- 2017-11-09
- Last updated
- 2023-07-24
- Results first posted
- 2023-07-24
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Who Were Headache Pain Free at 120 Minutes After Treatment | 120 minutes | Participants will self-report the severity of their headache. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Who Were Headache Pain Free at 120 Minutes After Treatment | 120 minutes | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Who Were Headache Pain Free at 120 Minutes After Treatment | Sumatriptan Nasal Powder | 8 | Participants | ||
| Number of Participants Who Were Headache Pain Free at 120 Minutes After Treatment | Placebo | 9 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Sumatriptan Nasal Powder | 79 | |
| Overall Study | STARTED | Placebo | 80 | |
| Overall Study | COMPLETED | Sumatriptan Nasal Powder | 75 | |
| Overall Study | COMPLETED | Placebo | 74 | |
| Overall Study | NOT COMPLETED | Sumatriptan Nasal Powder | 4 | |
| Overall Study | NOT COMPLETED | Placebo | 6 |
Source ClinicalTrials.gov
Adverse events8
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nasal Discomfort | Respiratory, thoracic and mediastinal disorders | Sumatriptan Nasal Powder | 2 | 79 | 2 |
| other | Nasal Discomfort | Respiratory, thoracic and mediastinal disorders | Placebo | 0 | 80 | 0 |
| other | Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | Sumatriptan Nasal Powder | 0 | 79 | 0 |
| other | Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | Placebo | 1 | 80 | 1 |
| other | Throat Irritation | Respiratory, thoracic and mediastinal disorders | Sumatriptan Nasal Powder | 0 | 79 | 0 |
| other | Throat Irritation | Respiratory, thoracic and mediastinal disorders | Placebo | 1 | 80 | 1 |
| other | Skin Burning Sensation | Skin and subcutaneous tissue disorders | Sumatriptan Nasal Powder | 1 | 79 | 1 |
| other | Skin Burning Sensation | Skin and subcutaneous tissue disorders | Placebo | 0 | 80 | 0 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Sumatriptan Nasal Powder | 3 | 79 |
| Total, all-cause mortality | Placebo | 2 | 80 |
| Total, other adverse events | Sumatriptan Nasal Powder | 3 | 79 |
| Total, other adverse events | Placebo | 2 | 80 |
| Total, serious adverse events | Sumatriptan Nasal Powder | 0 | 79 |
| Total, serious adverse events | Placebo | 0 | 80 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Sumatriptan Nasal Powder vs Placebo: Number of Participants Who Were Headache Pain Free at 120 Minutes After Treatment | Trial comparisons |
| Sumatriptan Nasal Powder vs Placebo: deaths from any cause | Trial comparisons |
| Sumatriptan Nasal Powder vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03338920
GET https://conductscience.org/api/trials/v1/NCT03338920/registered