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The study is being conducted to determine if OPTINOSE SUMATRIPTAN delivered nasally (through the nose) using the OPTINOSE SUMATRIPTAN Device can reduce the pain and symptoms associated with migraine headaches.
The primary objective for this study is to compare headache relief (defined as a reduction from moderate [Grade 2] or severe [Grade 3] pain to none [Grade 0] or mild [Grade 1] pain) at 120 minutes following a dose of 20 mg of OPTINOSE SUMATRIPTAN with placebo in the acute treatment of a single migraine attack.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sumatriptan | Active Comparator |
| |
| Matching placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sumatriptan | Drug | Sumatriptan 20mg |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Headache Relief | The primary objective for this study is to compare headache relief (defined as a reduction from moderate [Grade 2] or severe [Grade 3] pain to none [Grade 0] or mild [Grade 1] pain) at 120 minutes following a dose of 20 mg of OPTINOSE SUMATRIPTAN with placebo in the acute treatment of a single migraine attack. | 120 Minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Francisco Clinical Research Center | San Francisco | California | 94109 | United States | ||
| California Medical Clinic for Headache |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25355310 | Derived | Cady RK, McAllister PJ, Spierings EL, Messina J, Carothers J, Djupesland PG, Mahmoud RA. A randomized, double-blind, placebo-controlled study of breath powered nasal delivery of sumatriptan powder (AVP-825) in the treatment of acute migraine (The TARGET Study). Headache. 2015 Jan;55(1):88-100. doi: 10.1111/head.12472. Epub 2014 Oct 30. |
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Screening period (general medical exams, labs, medical and headache history, concomitant medications.
private practices and research clinics
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| ID | Title | Description |
|---|---|---|
| FG000 | Matching Placebo | Placebo : Matching placebo |
| FG001 | Sumatriptan | Sumatriptan : Sumatriptan 20mg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Drug |
Matching placebo |
|
| Santa Monica |
| California |
| 90404 |
| United States |
| Associated Neurologists of Southern CT, P.C. | Fairfied | Connecticut | 06824 | United States |
| Premiere Research Institute | West Palm Beach | Florida | 33407 | United States |
| MedVadis | Watertown | Massachusetts | 02472 | United States |
| Michigan Head and Pain Institute | Ann Arbor | Michigan | 48104-5199 | United States |
| ClinVest | Springfield | Missouri | 65807 | United States |
| Mercy Health Research | St Louis | Missouri | 63141 | United States |
| DENT Neurologic Institute | Amherst | New York | 14226 | United States |
| Headache Wellnes Center | Greensboro | North Carolina | 27405 | United States |
| PMG Research of Raleigh North carolina, LLC | Raleigh | North Carolina | 27609 | United States |
| PMG Research of Winston Salem, LLC | Winston-Salem | North Carolina | 27103 | United States |
| Neurology Center of Ohio | Toledo | Ohio | 43623 | United States |
| Jefferson Headache Center | Philadelphia | Pennsylvania | 19107 | United States |
| Coastal Carolina Research Center | Mt. Pleasant | South Carolina | 29464 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Matching Placebo | Placebo : Matching placebo |
| BG001 | Sumatriptan | Sumatriptan : Sumatriptan 20mg |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Headache Relief | The primary objective for this study is to compare headache relief (defined as a reduction from moderate [Grade 2] or severe [Grade 3] pain to none [Grade 0] or mild [Grade 1] pain) at 120 minutes following a dose of 20 mg of OPTINOSE SUMATRIPTAN with placebo in the acute treatment of a single migraine attack. | The full analysis dataset (FAD) will include all subjects who are randomized, receive study medication, and record at least one post-treatment assessment of pain severity. The treatment group assignment will be designated according to treatment received. The FAD will serve as the basis for the efficacy analyses. | Posted | Number | participants | 120 Minutes |
|
|
|
17 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Matching Placebo | Placebo : Matching placebo | 0 | 111 | 9 | 111 | ||
| EG001 | Sumatriptan | Sumatriptan : Sumatriptan 20mg | 0 | 112 | 45 | 112 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Product Taste Abnormal | General disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Nasal Discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Rhinitis | Infections and infestations | Medra 13.1 | Non-systematic Assessment |
|
Found in PI contract.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sr. Director of Clinical Development | OptiNose | (267) 364-3620 | jennifer.carothers@optinose.com |
| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| D006261 | Headache |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D018170 | Sumatriptan |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D014363 | Tryptamines |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| >=65 years |
|
| Male |
|