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
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
1,201
Dihydroergotamine is a semi-synthetic derivative of ergotamine tartrate.
Placebo for STS101
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
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
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
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