Migraine, Migraine With Aura, Migraine Without Aura
Conditions
Keywords
dihydroergotamine, dihydroergotamine mesylate, migraine
Brief summary
Study STS101-002 is a randomized, double-blind, parallel group, placebo-controlled, multicenter study to evaluate the efficacy, safety, and tolerability of single doses of STS101 (dihydroergotamine nasal powder) in the acute treatment of migraine
Detailed description
The EMERGE trial is a multi-center, single-dose, randomized, double-blind, placebo-controlled, parallel group study in subjects with acute migraine (ages 18 to 65 years).
Interventions
Dihydroergotamine is a semi-synthetic derivative of ergotamine tartrate.
DRUGPlacebos
Placebo for STS101
Sponsors
Satsuma Pharmaceuticals, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Males or females, 18-65 years of age at the time of Screening Visit * Subject has at least 1-year history of migraines (with or without aura), according to the International Classification of Headache Disorder, 3rd Edition (ICHD3)
Exclusion criteria
* Pregnant or breast-feeding women * Women of child-bearing potential not using or not willing to use highly effective contraception. * Diagnosis of headache conditions other than migraine with or without aura, including diagnosis of basilar or hemiplegic migraines or cluster headache. * History of coronary artery disease, coronary artery vasospasm (including Printz-metals' angina), clinically significant arrhythmia or, peripheral vascular disease, ischemic disease (e.g. Raynaud's syndrome, ischemic bowel syndrome, angina pectoris, myocardial infarction, or documented silent ischemia); percutaneous coronary intervention, or cardiac surgery. * History of cerebrovascular disease, including but not limited to stroke, transient ischemic attack, cerebral hemorrhage, subarachnoid hemorrhage. * Diagnosis of major depression with current symptoms, psychosis, alcohol abuse or dependence, drug abuse or dependence, major psychiatric conditions (e.g. schizophrenia, psychosis or Bipolar disorder), dementia. Other significant neurological or psychiatric disorders (including other pain syndromes or risk of suicide) that in the opinion of the investigator might interfere with study participation and assessments or subject safety. * Any clinically significant symptoms or conditions, including but not limited to central nervous system (e.g., seizures), cardiac, pulmonary, metabolic, renal, hepatic or gastrointestinal conditions or history of such conditions that, in the opinion of the investigator might interfere with study assessments or safety of participant.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects With Freedom From Migraine Headache Pain at 2 Hours Post Dose | 2 Hours Post-Dose | The subject's rating was documented on a four-point scale from no pain (= 0), mild pain (= 1), moderate pain (= 2) to severe pain (= 3). Pain freedom means the pain went from moderate (2) or severe (3) to no pain (0). |
| Percentage of Subjects With Freedom From Most-Bothersome Symptom at 2 Hours Post Dose | 2 Hours Post-Dose | Subjects were prompted to document the presence of 3 symptoms (photophobia, phonophobia, and nausea) immediately before study drug administration and during the treated migraine attack. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects With Relief From Migraine Headache Pain at 2 Hours Post Dose | 2 Hours Post Dose | The subject's rating was documented on a four-point scale from no pain (= 0), mild pain (= 1), moderate pain (= 2) to severe pain (= 3). Pain relief means the pain went from moderate (2) or severe (3) to mild pain (1) or no pain (0). |
Countries
United States
Participant flow
Recruitment details
The study was conducted at 119 sites in the United States.
Pre-assignment details
A total of 1201 participants were randomized in the study, of which 1065 reported a qualifying migraine attack, received study drug, and reported a post-dose efficacy evaluation for at least one time point at or before the 2-hour timepoint (mITT population).
Participants by arm
| Arm | Count |
|---|---|
| STS101 Low Dose Subjects received a single oral dose of STS101 (dihydroergotamine nasal powder) 3.9 mg. | 363 |
| STS101 High Dose Subjects received a single oral dose of STS101 (dihydroergotamine nasal powder) 5.2 mg. | 367 |
| STS101 Placebo Subjects received a single oral dose of Placebo for STS101 (dihydroergotamine nasal powder). | 363 |
| Total | 1,093 |
Baseline characteristics
| Characteristic | STS101 Low Dose | STS101 High Dose | STS101 Placebo | Total |
|---|---|---|---|---|
| Age, Customized Age Group (n (%)) 18-35 years | 123 Participants | 117 Participants | 122 Participants | 362 Participants |
| Age, Customized Age Group (n (%)) >30-50 years | 164 Participants | 186 Participants | 176 Participants | 526 Participants |
| Age, Customized Age Group (n (%)) >50-65 years | 76 Participants | 64 Participants | 65 Participants | 205 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants | 1 Participants | 3 Participants | 7 Participants |
| Race (NIH/OMB) Asian | 6 Participants | 12 Participants | 13 Participants | 31 Participants |
| Race (NIH/OMB) Black or African American | 55 Participants | 60 Participants | 41 Participants | 156 Participants |
| Race (NIH/OMB) More than one race | NA Participants | NA Participants | NA Participants | NA Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants | 1 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants | 1 Participants | 1 Participants | 6 Participants |
| Race (NIH/OMB) White | 293 Participants | 292 Participants | 304 Participants | 889 Participants |
| Region of Enrollment United States | 363 participants | 367 participants | 363 participants | 1093 participants |
| Sex: Female, Male Female | 318 Participants | 320 Participants | 317 Participants | 955 Participants |
| Sex: Female, Male Male | 45 Participants | 47 Participants | 46 Participants | 138 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 363 | 0 / 367 | 0 / 363 |
| other Total, other adverse events | 49 / 363 | 52 / 367 | 19 / 363 |
| serious Total, serious adverse events | 0 / 363 | 1 / 367 | 0 / 363 |
Outcome results
Primary
Percentage of Subjects With Freedom From Migraine Headache Pain at 2 Hours Post Dose
The subject's rating was documented on a four-point scale from no pain (= 0), mild pain (= 1), moderate pain (= 2) to severe pain (= 3). Pain freedom means the pain went from moderate (2) or severe (3) to no pain (0).
Time frame: 2 Hours Post-Dose
Population: The analysis was performed on the mITT population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| STS101 Low Dose | Percentage of Subjects With Freedom From Migraine Headache Pain at 2 Hours Post Dose | 69 Participants |
| STS101 High Dose | Percentage of Subjects With Freedom From Migraine Headache Pain at 2 Hours Post Dose | 68 Participants |
| STS101 Placebo | Percentage of Subjects With Freedom From Migraine Headache Pain at 2 Hours Post Dose | 53 Participants |
Primary
Percentage of Subjects With Freedom From Most-Bothersome Symptom at 2 Hours Post Dose
Subjects were prompted to document the presence of 3 symptoms (photophobia, phonophobia, and nausea) immediately before study drug administration and during the treated migraine attack.
Time frame: 2 Hours Post-Dose
Population: This analysis was conducted on the mITT population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| STS101 Low Dose | Percentage of Subjects With Freedom From Most-Bothersome Symptom at 2 Hours Post Dose | 133 Participants |
| STS101 High Dose | Percentage of Subjects With Freedom From Most-Bothersome Symptom at 2 Hours Post Dose | 139 Participants |
| STS101 Placebo | Percentage of Subjects With Freedom From Most-Bothersome Symptom at 2 Hours Post Dose | 119 Participants |
Secondary
Percentage of Subjects With Relief From Migraine Headache Pain at 2 Hours Post Dose
The subject's rating was documented on a four-point scale from no pain (= 0), mild pain (= 1), moderate pain (= 2) to severe pain (= 3). Pain relief means the pain went from moderate (2) or severe (3) to mild pain (1) or no pain (0).
Time frame: 2 Hours Post Dose
Population: This analysis was conducted on the mITT population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| STS101 Low Dose | Percentage of Subjects With Relief From Migraine Headache Pain at 2 Hours Post Dose | 180 Participants |
| STS101 High Dose | Percentage of Subjects With Relief From Migraine Headache Pain at 2 Hours Post Dose | 177 Participants |
| STS101 Placebo | Percentage of Subjects With Relief From Migraine Headache Pain at 2 Hours Post Dose | 166 Participants |