Clinical Trial Search

Primary: The Percentage of Subjects in the Double-blind Period Who Are Pain Free at 2 Hours After Dosing as Reported by the Subject in the eDiary — 51.0; 30.8 Percentage of…

Primary: Pain Relief at 2 Hours During the First Migraine Attack Period — 246; 30; 74; 52 participants

Primary: Mean Change From Baseline in the Number of Migraine Headache Days in the Last 28-day Period of the 12-week Treatment Phase — -4.2; -3.0 Migraine headache days

Primary: Headache Relief (Modified LOCF - Efficacy Evaluable Analysis Set) — 42; 30 Participants

Primary: Migraine Functional Impairment as Measured by Score on the Headache Impact Test 6 (HIT6) Scale — 59; 56 units on a scale

Primary: Change in Migraine Characteristics — 43; 2; 17 Participants

Primary: Percentage Decrease in Migraine Episodes — 48; 57; 46 Percentage decrease in migraine episodes — p=0.6207

Primary: Change in Number of Monthly Migraine Headache Days — -3.5; -1.1 migraine days

Primary: Sustained Freedom From Migraine Pain Between 2-24 Hours Post-dose — 10; 41 Participants — p=<0.001

Primary: Number of Participants With Pain Freedom (PF) at 2 Hours Post-Dose — 56; 89; 101; 29 Participants — p=<0.001

Primary: Time (Hours) to First Use of Rescue Medication — NA; NA; NA hours — p=0.6407

Primary: Percentage of Participants Who Discontinued Due to Adverse Event — 4.65; 4.96 Percentage of Participants — p=1

Primary: Percentage of Participants Experiencing no Pain at Two Hours Post-treatment — 39; 22 percentage of participants

Primary: Sustained Freedom From Migraine Pain Between 2-24 Hours Post-dose — 10; 36 Participants — p=<0.001

Primary: Change in MMD (Monthly Migraine Days) — -3.04; -2.14 migraine days per month

Primary: Total Number of Responders — 17 Participants

Primary: Migraine Headache Days — 7.12; 6.92; 5.53; 4.79 Days

Primary: Percentage of Participants With Reduction of Migraine Headache at 2 Hours Post Treatment — 66; 40 Participants

Primary: Presence or Absence of Prophylactic Medication for Headache/Migraine — 166; 227; 18; 48 Participants

Primary: Pain-Relief at 2 Hours Post-treatment — 56; 65; 66 Participants

Primary: Percentage of Subjects Reporting Headache Pain Freedom — 85; 14 Participants — p=<0.001

Primary: The Number of Subjects With a Numeric Rating Scale Score (NRS) of Zero at Two Hours. — 5; 12 participants — p=0.03

Primary: Pain Freedom at 2 Hours Post Treatment — 15; 14 Participants — p=0.7194

Primary: Number of Subjects With Pain Relief at 2 Hours From Time of First Dose — 136; 231 participants

Primary: Persistent Headache Pain Free at 24 Hours — 26; 19 Participants

Primary: Change in Migraine Headache Pain Score From Time of Dosing (0 Minutes) — 0; 0.2; -0.8; -0.2 score on a scale — p=0.9733

Primary: Change From Baseline in Mean Monthly Hours of at Least Moderate Headache Pain Intensity Over Months 1, 2, and 3 — -23.38; -31.33 hours/month — p=< 0.001

Primary: Percentage of Subjects Achieving Headache Pain Freedom at Hour 2 — 43; 22 Participants — p=0.002

Primary: Percentage of Participants Who Are Headache Pain Free — 28.2; 32.2; 15.3 percentage of participants — p=<0.001

Primary: Percentage of Participants With Pain Freedom at Two Hours Post-dose — 10.9; 35.2; 38.3; 31.2 Percentage of Participants — p=<0.001