Migraine, Migraine With Aura, Migraine Without Aura
Conditions
Keywords
dihydroergotamine, dihydroergotamine mesylate, migraine
Brief summary
Study STS101-007 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
Study STS101-007 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.
DRUGPlacebo
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) Key
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
Pre-assignment details
A total of 1591 participants were randomized in the study, of which 1424 reported a qualifying migraine attack, received study drug, and reported efficacy data in at least one post-treatment e-diary (modified intent to treat population).
Participants by arm
| Arm | Count |
|---|---|
| STS101 5.2 mg Subjects received a single oral dose of STS101 (dihydroergotamine nasal powder) 5.2 mg | 716 |
| STS101 Placebo Subjects received a single oral dose of Placebo for STS101 (dihydroergotamine nasal powder) | 708 |
| Total | 1,424 |
Baseline characteristics
| Characteristic | STS101 5.2 mg | STS101 Placebo | Total |
|---|---|---|---|
| Age, Customized 18-35 years | 312 Participants | 297 Participants | 609 Participants |
| Age, Customized >35-50 years | 286 Participants | 283 Participants | 569 Participants |
| Age, Customized >50-65 years | 118 Participants | 128 Participants | 246 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 5 Participants | 3 Participants | 8 Participants |
| Race (NIH/OMB) Asian | 25 Participants | 24 Participants | 49 Participants |
| Race (NIH/OMB) Black or African American | 86 Participants | 97 Participants | 183 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants | 3 Participants | 5 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 7 Participants | 5 Participants | 12 Participants |
| Race (NIH/OMB) White | 591 Participants | 576 Participants | 1167 Participants |
| Region of Enrollment United States | 716 participants | 708 participants | 1424 participants |
| Sex: Female, Male Female | 567 Participants | 564 Participants | 1131 Participants |
| Sex: Female, Male Male | 149 Participants | 144 Participants | 293 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 731 | 0 / 729 |
| other Total, other adverse events | 111 / 731 | 14 / 729 |
| serious Total, serious adverse events | 3 / 731 | 0 / 729 |
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 5.2 mg | Percentage of Subjects With Freedom From Migraine Headache Pain at 2 Hours Post Dose | 146 Participants |
| STS101 Placebo | Percentage of Subjects With Freedom From Migraine Headache Pain at 2 Hours Post Dose | 124 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 5.2 mg | Percentage of Subjects With Freedom From Most-Bothersome Symptom at 2 Hours Post Dose | 265 Participants |
| STS101 Placebo | Percentage of Subjects With Freedom From Most-Bothersome Symptom at 2 Hours Post Dose | 230 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 5.2 mg | Percentage of Subjects With Relief From Migraine Headache Pain at 2 Hours Post Dose | 379 Participants |
| STS101 Placebo | Percentage of Subjects With Relief From Migraine Headache Pain at 2 Hours Post Dose | 316 Participants |