Clinical Trial Search

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

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: A Change in the Frequency of Cluster Headache Attacks Per Week — -2.0; -7.6 CH attacks per week

Primary: Percentage of Subjects Who Achieve Pain Relief — 3; 5; 5 Participants

Primary: Number of Participants With Treatment-emergent Adverse Events (AEs) — 106 Participants

Primary: Number of Participants With Repsonse to Treatment — 14; 16; 57; 44 Participants

Primary: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious AEs (SAEs) — 119; 17 Participants

Primary: Overall Mean Change From Baseline in Weekly Cluster Headache Attack Frequency — -4.59; -5.38 cluster headache attacks per week — p=0.334

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: Number of Participants Who Report Moderate or Severe Pain Within 24 Hours of Emergency Department(ED) Discharge — 53; 6; 20 Participants

Primary: Time Required to Achieve a Greater Than or Equal to 50% Reduction in Frequency or Severity of Individual Cluster Attacks Compared to Subject-reported Baseline. — 29.7 days

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

Primary: Prevalence of Allodynia in Subjects With Cluster Headache — 20 participants

Primary: Reduction in Headache Intensity — 6; 4; 1; 3 Participants

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

Primary: Headache Pain Relief at 2 hr Post-dose by 2-point Definition — 6; 11; 13 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: Change in Mean Number of Days Per Month With Significant Mid-facial Pain or Pressure — -6.0; -5.8 days per month — p=0.96

Primary: Number of Subjects With Daily Headache Who Have Continuous Headache — 18; 27 participants

Primary: Percentage of Participants With 50% Response Rate Across the 3-month Treatment Period. — 62; 61 percentage of participants — p=0.695

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

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

Primary: Change in Headache Relief — 23 percentage of headaches resolved — p=.079

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

Primary: The Difference Between the Active and Sham Treatment Groups in Morphine Equivalence Dosage PER DAY — 0.058; 0.24 mg

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

Primary: Total Number of Responders — 17 Participants

Primary: Number of Participants With a Reduction in Headache Days From Baseline to Month 8 of Treatment — 3; 1; 1; 0 participants

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