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

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: 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 Participants With Treatment Emergent Adverse Events (TEAEs) and Serious AEs (SAEs) — 119; 17 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: Percentage of Subjects Who Achieve Pain Relief — 3; 5; 5 Participants

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

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

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

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

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

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

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

Primary: Percentage of Participants With Episodic Migraine (EM) or Chronic Migraine (CM) — 91.2; 8.8 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: Change in Optic Nerve Sheath Diameter by Ultrasonography — 0.02; 0.02 mm — p=0.98

Primary: Time to Relief (Min) — 92.2; 83.9; 35.4 Minutes

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

Primary: Persistent Headache Pain Free at 24 Hours — 26; 19 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: Headache Following Intervention — 63.5; 43.5 mm

Primary: Number of Participants With Sustained Headache Relief — 12 Participants

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

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

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

Primary: Average Numeric Pain Score — 5.2; 5.8 score on a scale — p=0.7