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.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
1,591
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
MD First Research
Chandler, Arizona, United States
Elite Clinical Studies
Phoenix, Arizona, United States
Alliance For Multispecialty Research
Tempe, Arizona, United States
Cognitive Clinical Trials, LLC
Tempe, Arizona, United States
Clinedge, LLC
Tucson, Arizona, United States
ERG Clinical
Little Rock, Arkansas, United States
Hope Clinical Research
Canoga Park, California, United States
Wr-Pri, Llc
Encino, California, United States
Neuro-Pain Medical Center Ince
Fresno, California, United States
Estudy Site - La Mesa
La Mesa, California, United States
...and 117 more locations