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.
Primary Outcome Measures :
- Pain Freedom at 2 Hours [ Time Frame: 2 Hours Post-Dose ]
Proportion of subjects free from headache pain at 2 hours post dose
- Freedom From Most-Bothersome Symptom at 2 Hours [ Time Frame: 2 Hours Post-Dose ]
Proportion of subjects free from most bothersome symptom (MBS) among photophobia, phonophobia and nausea at 2 hours post dose
Secondary Outcome Measures :
- Sustained Pain-Free [ Time Frame: Up to 48 hours post-dosing ]
Proportion of subjects free from headache pain at 2 hours post dose and remaining headache free at 24 hours post dose with no use of rescue medication and no relapse of any headache pain
- Rescue Medication Usage [ Time Frame: Up to 48 hours post-dosing ]
Proportion of subjects who use rescue medication
- Pain Relapse [ Time Frame: Up to 48 hours post-dosing ]
Proportion of subjects with headache relapse (defined as the return of headache of any severity within 24 hours post dosing of the investigational drug, when the subject was pain-free at 2 hours after investigational drug administration)
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)
- BMI under 31
Qualified Participants May Receive:
Up to $1,350 compensation, complimentary transportation to and from appointments and meals are provided.