Clinical Trial Search

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

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

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: Number of Participants With Treatment-emergent Adverse Events (AEs) — 106 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: Number of Subjects With Daily Headache Who Have Continuous Headache — 18; 27 participants

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

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

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

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

Primary: Percentage of Participants With Episodic Migraine (EM) or Chronic Migraine (CM) — 91.2; 8.8 percentage of 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: Change in the Number of Moderate to Severe Headache Days Within a 28 Day Average Period in Six Months Compared to Baseline — 4.4; 4.7 Moderate to severe headache days…

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

Primary: Change in Number of Headache Days Per Month From Baseline (BL) to Months 1 Through 7. — -7.61; -6.67; -9.72; -5.22 days

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

Primary: Change in Headache Days/Month After 4 Years Compared to Baseline — 6.6 headache days/month

Primary: Percentage of Participants Admitted to the Hospital for Headache — 6.0; 2.1 percentage of participants

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

Primary: Pain Intensity — 5.82; 4.92 score on a scale

Primary: Change From Baseline in the Frequency of Headache Days — 22.0; -10.7 headache days

Primary: Number of Participants With Any Treatment Emergent Adverse Events (TEAEs) — 91 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: Visual Analog Scale — 8.3; 8.4; 5.3; 5.3 units on a scale

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: Total Number of Responders — 17 Participants

Primary: 75% Migraine Responder Rate — 38; 37; 33; 33 Participants — p=0.0330

Primary: Subject Global Impression of Change — 4.43; 5.67; 1.67; 4.76 units on a scale

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

Primary: Numeric Rating Scale (NRS) — 3.18; 3.78; 2.53; 3.51 units on a scale