Trial · NCT01667679
Efficacy and Safety of 20 mg Sumatriptan Powder Delivered Intranasally With the Bi-directional Device Compared With 100 mg Sumatriptan Tablets in Adults With Acute Migraine With or Without Aura
NCT01667679, Phase 3, Completed, Avanir Pharmaceuticals; results first posted 2017-03-14
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety of 20 mg Sumatriptan Powder Delivered Intranasally With the Bi-directional Device Compared With 100 mg Sumatriptan Tablets in Adults With Acute Migraine With or Without Aura. Trials, record NCT01667679. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01667679
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of 20 mg Sumatriptan Powder Delivered Intranasally With the Bi-directional Device Compared With 100 mg Sumatriptan Tablets in Adults With Acute Migraine With or Without Aura
- NCT number
- NCT01667679
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 275 participants, actual
- Lead sponsor
- Avanir Pharmaceuticals
- Conditions
- Migraine, Headaches
- Interventions
- 100 mg Sumatriptan Tablet and OPTINOSE Placebo delivered nasally, OPTINOSE SUMATRIPTAN delivered nasally and placebo tablet
- First posted
- 2012-08-17
- Last updated
- 2017-04-12
- Results first posted
- 2017-03-14
Source ClinicalTrials.gov
Registered outcomes27
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Sum of Migraine Pain Intensity Differences (SPID)-30 | Baseline and 30 minutes post-dose (up to 24 weeks) | SPID-30 is defined as the sum of the pain intensity differences (measured as area under the curve) from dosing (Baseline) through 30 minutes post-dose for headaches with a Baseline intensity of mild, moderate, or severe. The range of possible scores is -60 to +90. A higher number indicates a greater reduction in pain intensity. Negative values indicate worsening pain. A value of "0" indicates that there was no change in pain intensity from Baseline through 30 minutes. Results are from an analysis of covariance (ANCOVA) model with treatment, period, and treatment sequence as fixed effects and participant as a random effect. The Last Observation Carried Forward (LOCF) imputation method (missing values were replaced by carrying forward the preceding value) was used for this analysis. |
| Secondary | Mean Sum of Migraine Pain Intensity Differences (SPID)-30 for Headaches With a Baseline Intensity of Mild and Moderate/Severe | Baseline and 30 minutes post-dose (up to 24 weeks) | SPID-30 is defined as the sum of the pain intensity differences (measured as area under the curve) from dosing (Baseline) through 30 minutes post-dose for headaches with a Baseline intensity of mild and moderate/severe (rated on a 4-point scale: 0=none, 1=mild, 2=moderate, and 3=severe). The range of possible scores for all participants is -60 to +90. For participants with a mild headache at Baseline, the SPID range is -60 to +30. For participants with a moderate/severe headache at Baseline, the SPID range is -30 to +90. A higher number indicates a greater reduction in pain intensity. Negative values indicate worsening pain. A value of "0" indicates that there was no change in pain intensity from Baseline through 30 minutes. Results are from an ANCOVA model with treatment, period, and treatment sequence as fixed effects and participant as a random effect. The LOCF imputation method (missing values were replaced by carrying forward the preceding value) was used for this analysis. |
| Secondary | Percentage of Attacks in Which Pain Reduction Was Achieved | 10, 15, 30, 45, 60, 90, and 120 minutes | Percentage of attacks in which pain reduction (defined as a decrease in pain intensity of at least one point on the following scale: 0, none; 1, mild; 2, moderate; 3, severe) was achieved at 10, 15, 30, 45, 60, 90, and 120 minutes after the initial dose for all attacks. |
| Secondary | Percentage of Attacks in Which Pain Freedom Was Achieved | Baseline and 10, 15, 30, 45, 60, 90, and 120 minutes post-dose (up to 24 weeks) | Percentage of attacks in which pain freedom (defined as pain level reduced to none \[Grade 0\]) was achieved at 10, 15, 30, 45, 60, 90, and 120 minutes after the initial dose for all attacks. |
| Secondary | Percentage of Attacks in Which Pain Relief Was Achieved | Baseline and 10, 15, 30, 45, 60, 90, and 120 minutes post-dose (up to 24 weeks) | Percentage of attacks treated at a severity of moderate (Grade 2) or severe (Grade 3) in which pain relief (defined as pain level reduced to none \[Grade 0\] or mild \[Grade 1\]) was achieved at 10, 15, 30, 45, 60, 90, and 120 minutes after the initial dose for all attacks. |
| Secondary | Median Time to Pain Freedom | 120 minutes post-dose (up to 24 weeks) | Pain freedom is defined as a pain level reduced to none (Grade 0). |
| Secondary | Mean Change in Headache Severity From Baseline to 10, 15, 30, 45, 60, 90, and 120 Minutes Post-dose | Baseline and 10, 15, 30, 45, 60, 90, and 120 minutes post-dose (up to 24 weeks) | Participants were required to record their headache severity score in their e-diaries immediately before intake of study medication (Baseline) and at 10, 15, 30, 45, 60, 90, and 120 minutes post-dose. Participants graded their headaches on the following severity scale: 0, none; 1, mild; 2, moderate; 3, severe. Mean change from Baseline was calculated as the post-Baseline value minus the Baseline value. |
| Secondary | Mean Change From Baseline in Clinical Disability Score at 10, 15, 30, 45, 60, 90, and 120 Minutes Post-dose | Baseline and 10, 15, 30, 45, 60, 90, and 120 minutes post-dose (up to 24 weeks) | Participants were required to record their clinical disability score in their e-diaries immediately before intake of study medication (Baseline) and at 10, 15, 30, 45, 60, 90, and 120 minutes post-dose. Participants graded their disability on the following scale: 0, no disability, able to function normally; 1, performance of daily activities mildly impaired, can still do everything but with difficulty; 2, performance of daily activities moderately impaired, unable to do some things; 3, performance of daily activities severely impaired, cannot do all or most things, bed rest may be necessary. Mean change from Baseline was calculated as the post-Baseline value minus the Baseline value. |
| Secondary | Number of Participants With Any Treatment-emergent Non-serious and Serious Adverse Event | Baseline compared to Vist 2, 3 and 4 | An adverse event is defined as any untoward medical occurrence associated with the use of an investigational product in humans, whether or not it is considered related to the investigational product. This includes any occurrence that was new in onset or aggravated in severity or frequency from the Baseline condition. |
| Secondary | Change From Baseline in Hemoglobin at Visit 3 (up to 12 Weeks) and Visit 4 (up to 24 Weeks) | Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks) | Change from Baseline in hemoglobin was assessed at Visit 3 (the start of Treatment Period 2) and Visit 4 (the end-of-study visit). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1. |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 registered outcomesOutcomes27
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Sum of Migraine Pain Intensity Differences (SPID)-30 | Baseline and 30 minutes post-dose (up to 24 weeks) | Full Analysis Set (FAS): all participants who experienced at least 1 headache attack per treatment period, received at least 1 dose of study medication (sumatriptan nasal powder or tablet) in each treatment period, and had at least 1 post-Baseline assessment for a treated attack in each treatment period. | scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Sum of Migraine Pain Intensity Differences (SPID)-30 for Headaches With a Baseline Intensity of Mild and Moderate/Severe | Baseline and 30 minutes post-dose (up to 24 weeks) | FAS. Only those participants with the type of attack specified were analyzed (specified by n=X, X in the corresponding category title). A single participant could have had both a mild and a moderate/severe attack. | scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Attacks in Which Pain Reduction Was Achieved | 10, 15, 30, 45, 60, 90, and 120 minutes | FAS. The LOCF imputation method was used in this analysis. | percentage of attacks | NUMBER |
| SECONDARY | Percentage of Attacks in Which Pain Freedom Was Achieved | Baseline and 10, 15, 30, 45, 60, 90, and 120 minutes post-dose (up to 24 weeks) | FAS. The LOCF imputation method was used for this analysis. | percentage of attacks | NUMBER |
| SECONDARY | Percentage of Attacks in Which Pain Relief Was Achieved | Baseline and 10, 15, 30, 45, 60, 90, and 120 minutes post-dose (up to 24 weeks) | FAS. The LOCF imputation method was used in this analysis. | percentage of attacks | NUMBER |
| SECONDARY | Median Time to Pain Freedom | 120 minutes post-dose (up to 24 weeks) | FAS. If the participant did not report pain freedom within 120 minutes post-dose, he/she was considered to be censored at the last non-missing result prior to the 120-minute time point. | minutes | MEDIAN |
| SECONDARY | Mean Change in Headache Severity From Baseline to 10, 15, 30, 45, 60, 90, and 120 Minutes Post-dose | Baseline and 10, 15, 30, 45, 60, 90, and 120 minutes post-dose (up to 24 weeks) | FAS. The LOCF imputation method was used for this analysis. Results are from an ANCOVA model with treatment, period, and treatment sequence as fixed effects and participant as a random effect. | scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline in Clinical Disability Score at 10, 15, 30, 45, 60, 90, and 120 Minutes Post-dose | Baseline and 10, 15, 30, 45, 60, 90, and 120 minutes post-dose (up to 24 weeks) | FAS. The LOCF imputation method was used for this analysis. Results are from an ANCOVA model with treatment, period, and treatment sequence as fixed effects and participant as a random effect. | scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Participants With Any Treatment-emergent Non-serious and Serious Adverse Event | Baseline compared to Vist 2, 3 and 4 | Safety Analysis Set: all randomized participants who received at least 1 dose of either 20 mg sumatriptan nasal powder or 100 mg sumatriptan tablet | participants | NUMBER |
| SECONDARY | Change From Baseline in Hemoglobin at Visit 3 (up to 12 Weeks) and Visit 4 (up to 24 Weeks) | Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks) | Safety Analysis Set. Only those participants with data available at Visit 3 and Visit 4 were assessed at that respective visit (indicated by n=X, X in the category titles). | grams per Liter (g/L) | MEAN |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 outcomesResults by group466
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Sum of Migraine Pain Intensity Differences (SPID)-30 | 20 mg Sumatriptan Nasal Powder | 10.80 | Standard Error 0.880 | scores on a scale | |
| Mean Sum of Migraine Pain Intensity Differences (SPID)-30 | 100 mg Sumatriptan Tablet | 7.41 | Standard Error 0.880 | scores on a scale | |
| Mean Sum of Migraine Pain Intensity Differences (SPID)-30 for Headaches With a Baseline Intensity of Mild and Moderate/Severe | 20 mg Sumatriptan Nasal Powder | mild attacks, n=113, 109 | 3.90 | Standard Error 0.921 | scores on a scale |
| Mean Sum of Migraine Pain Intensity Differences (SPID)-30 for Headaches With a Baseline Intensity of Mild and Moderate/Severe | 100 mg Sumatriptan Tablet | mild attacks, n=113, 109 | 0.24 | Standard Error 0.931 | scores on a scale |
| Mean Sum of Migraine Pain Intensity Differences (SPID)-30 for Headaches With a Baseline Intensity of Mild and Moderate/Severe | 20 mg Sumatriptan Nasal Powder | moderate/severe attacks, n=158, 168 | 13.83 | Standard Error 1.022 | scores on a scale |
| Mean Sum of Migraine Pain Intensity Differences (SPID)-30 for Headaches With a Baseline Intensity of Mild and Moderate/Severe | 100 mg Sumatriptan Tablet | moderate/severe attacks, n=158, 168 | 10.07 | Standard Error 0.997 | scores on a scale |
| Percentage of Attacks in Which Pain Reduction Was Achieved | 20 mg Sumatriptan Nasal Powder | 10 minutes post-dose | 11.5 | percentage of attacks | |
| Percentage of Attacks in Which Pain Reduction Was Achieved | 100 mg Sumatriptan Tablet | 10 minutes post-dose | 10.2 | percentage of attacks | |
| Percentage of Attacks in Which Pain Reduction Was Achieved | 20 mg Sumatriptan Nasal Powder | 15 minutes post-dose | 26.4 | percentage of attacks | |
| Percentage of Attacks in Which Pain Reduction Was Achieved | 100 mg Sumatriptan Tablet | 15 minutes post-dose | 19.6 | percentage of attacks |
1 to 10 of 466Source ClinicalTrials.gov
See all 466 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Treatment Period 1 (<=12 Weeks) | STARTED | 20 mg Sumatriptan+PBO (TP1)/100 mg Sumatriptan+PBO (TP2) | 138 | |
| Treatment Period 1 (<=12 Weeks) | STARTED | 100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2) | 137 | |
| Treatment Period 1 (<=12 Weeks) | COMPLETED | 20 mg Sumatriptan+PBO (TP1)/100 mg Sumatriptan+PBO (TP2) | 122 | |
| Treatment Period 1 (<=12 Weeks) | COMPLETED | 100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2) | 107 | |
| Treatment Period 1 (<=12 Weeks) | NOT COMPLETED | 20 mg Sumatriptan+PBO (TP1)/100 mg Sumatriptan+PBO (TP2) | 16 | |
| Treatment Period 1 (<=12 Weeks) | NOT COMPLETED | 100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2) | 30 | |
| Treatment Period 2 (<=12 Weeks) | STARTED | 20 mg Sumatriptan+PBO (TP1)/100 mg Sumatriptan+PBO (TP2) | 122 | |
| Treatment Period 2 (<=12 Weeks) | STARTED | 100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2) | 107 | |
| Treatment Period 2 (<=12 Weeks) | COMPLETED | 20 mg Sumatriptan+PBO (TP1)/100 mg Sumatriptan+PBO (TP2) | 100 | |
| Treatment Period 2 (<=12 Weeks) | COMPLETED | 100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2) | 85 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events24
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 | Nausea | Gastrointestinal disorders | 20 mg Sumatriptan Nasal Powder | 9 | 219 | |
| other | Nausea | Gastrointestinal disorders | 100 mg Sumatriptan Tablet | 7 | 228 | |
| other | Product taste abnormal | General disorders | 20 mg Sumatriptan Nasal Powder | 57 | 219 | |
| other | Product taste abnormal | General disorders | 100 mg Sumatriptan Tablet | 9 | 228 | |
| other | Ear infection | Infections and infestations | 20 mg Sumatriptan Nasal Powder | 1 | 219 | |
| other | Ear infection | Infections and infestations | 100 mg Sumatriptan Tablet | 3 | 228 | |
| other | Gastroenteritis viral | Infections and infestations | 20 mg Sumatriptan Nasal Powder | 1 | 219 | |
| other | Gastroenteritis viral | Infections and infestations | 100 mg Sumatriptan Tablet | 3 | 228 | |
| other | Sinusitis | Infections and infestations | 20 mg Sumatriptan Nasal Powder | 3 | 219 | |
| other | Sinusitis | Infections and infestations | 100 mg Sumatriptan Tablet | 4 | 228 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 20 mg Sumatriptan Nasal Powder | ||
| Total, all-cause mortality | 100 mg Sumatriptan Tablet | ||
| Total, other adverse events | 20 mg Sumatriptan Nasal Powder | 98 | 219 |
| Total, other adverse events | 100 mg Sumatriptan Tablet | 35 | 228 |
| Total, serious adverse events | 20 mg Sumatriptan Nasal Powder | 0 | 219 |
| Total, serious adverse events | 100 mg Sumatriptan Tablet | 0 | 228 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| 20 mg Sumatriptan Nasal Powder vs 100 mg Sumatriptan Tablet: serious adverse events |
Source 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.
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