Migraine Clinical Trial
Official title:
A Double-Blind, Placebo-Controlled, Parallel Group Multicenter Study to Assess the Safety, Tolerance and Efficacy of a Single Subcutaneous Dose of TEZAMPANEL in Patients With Acute Migraine
To evaluate the effects of a single sc administration of TEZAMPANEL at one of three different dosage levels compared to placebo, employing traditional measures of efficacy and safety in the treatment of a single episode of acute migraine.
Primary:
• Headache relief (headache response) defined as the percentage of patients in each
treatment group who experience a decrease in pain from moderate or severe intensity pre-dose
(baseline) to mild or no pain 2 hours after study drug administration and prior to use of
rescue medication.
Secondary:
- Percentage of patients in each treatment group who are pain-free two hours after study
drug administration, prior to the use of any rescue medication
- Sustained headache response rate (percentage of patients in each treatment group with
headache response at Hour 2 and no rescue medication or headache recurrence from 2
through 24 hours)
- Sustained pain-free rate (percentage of patients in each treatment group who are pain
free at Hour 2 with no rescue medication or headache recurrence from 2 through 48
hours)
- Recurrence rate (percentage of patients in each treatment group with an Hour 2 mild
response or pain-free response who subsequently develop a headache rated as moderate to
severe in intensity within 2 to 24 hours)
- Relapse rate (percentage of patients in each treatment group with an Hour 2 pain free
response who subsequently develop a headache rated as moderate to severe in intensity
within 2 to 48 hours
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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