Clinical Trial Search

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

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

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

Primary: Headache Days — 23.64; 24.33 Days — p=0.83

Primary: Comparison of the Headache Pain Free Attack Rates at 15 Minutes Following the Treatment — 495; 400; 67; 46 Number of attacks

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

Primary: Change From Baseline in Monthly Migraine Days (Weeks 1-12) — -4.3; -3.9; -4.1; -3.1 Migraine Days — p=0.0001

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

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: Change in Mean Headache Index Score Among Patients — -1.52 headache index score

Primary: Number of Participants With Clinical Adverse Events (AEs) — 1582; 804 Participants

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

Primary: Proportion of Patients With Treatment Discontinuation Due to an Adverse Event (AE) During the Double-blind Treatment Epoch/Period (DBTE) — 41; 151 Participants — p=<.001

Primary: Total Number of Responders — 17 Participants

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

Primary: Percentage of Participants With Episodic Migraine (EM) or Chronic Migraine (CM) — 91.2; 8.8 percentage of participants

Primary: Change From Baseline in the Number of Weekly Cluster Headache (CH) Attacks, Averaged Over Weeks 1-2 — -4.0; -4.6 Number of Weekly Attacks — p=0.5048

Primary: Change From Baseline in Monthly Migraine Days at the Last Month (Month 3) of the Double-blind Treatment Period (DBTP) — -4.20; -4.79; -3.10 Migraine days/month — p=0.002

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

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

Primary: Placebo-controlled Period: Change From Baseline in the Number of MMDs at Weeks 1 - 4 — -6.85; -3.66 days/month — p=<0.0001

Primary: Percentage of Participants With ≥ 50% Reduction in Migraine Frequency During the Treatment Period — 48.1; 48.9 percentage of participants — p=0.954

Primary: Headache Days as Self-reported by Participants — 3.0; 3.3 days

Primary: Change in Pain Score — 3.8; 5.1 units on a scale

Primary: Headache Pain Relief at 2 hr Post-dose by 2-point Definition — 6; 11; 13 Participants

Primary: Number of Participants With Adverse Events — 110; 85; 79 Participants

Primary: Overall Mean Change From Baseline in Number of Weekly Cluster Headache Attacks — -5.22; -8.69 Cluster Headache Attacks per Week — p=0.036

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

Primary: Percent Change of Headache Days Compared to Baseline — -13.50; -36.50 percent change of headache days