Migraine Headache
Conditions
Keywords
Migraine, Headache, Sumatriptan
Brief summary
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.
Detailed description
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.
Interventions
DRUGSumatriptan
Sumatriptan 20mg
DRUGPlacebo
Matching placebo
Sponsors
Optinose US Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Men or women, between the ages of 18 to 65 years * Diagnosis of migraine, with or without aura * Experiences between 1 and 8 migraine attacks per month for the past 12 months
Exclusion criteria
* Inability to distinguish other headaches from migraine * Experiences headache of any kind at a frequency greater than or equal to 15 days per month * History of resistance to sumatriptan, or non-response to 2 or more other triptans, defined as subjects who have not responded to an adequate dose and duration of treatment * Current use of medication for migraine prophylaxis that has not been stable (no dose adjustment) for 30 days prior to screening * Chronic opioid therapy (\>3 consecutive days in the 30 days prior to screening)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Headache Relief | 120 Minutes | 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. |
Countries
United States
Participant flow
Recruitment details
private practices and research clinics
Pre-assignment details
Screening period (general medical exams, labs, medical and headache history, concomitant medications.
Participants by arm
| Arm | Count |
|---|---|
| Matching Placebo Placebo : Matching placebo | 111 |
| Sumatriptan Sumatriptan : Sumatriptan 20mg | 112 |
| Total | 223 |
Baseline characteristics
| Characteristic | Sumatriptan | Matching Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 112 Participants | 111 Participants | 223 Participants |
| Age, Continuous | 42.2 years STANDARD_DEVIATION 10.27 | 42.3 years STANDARD_DEVIATION 10.71 | 42.2 years STANDARD_DEVIATION 10.47 |
| Region of Enrollment United States | 112 participants | 111 participants | 223 participants |
| Sex: Female, Male Female | 94 Participants | 93 Participants | 187 Participants |
| Sex: Female, Male Male | 18 Participants | 18 Participants | 36 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 9 / 111 | 45 / 112 |
| serious Total, serious adverse events | 0 / 111 | 0 / 112 |
Outcome results
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.
Time frame: 120 Minutes
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Matching Placebo | Headache Relief | 47 participants |
| Sumatriptan | Headache Relief | 73 participants |