NCT00567086

Study to Assess the Safety, Tolerance and Efficacy of Tezampanel in Patients With Acute Migraine

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 306 (actual)
• Sponsor: TorreyPines Therapeutics · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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

Conditions

• Migraine

Interventions

Type	Name	Description
DRUG	TEZAMPANEL	Single Administration of: TEZAMPANEL 40 mg; TEZAMPANEL 70 mg; TEZAMPANEL 100 mg; Placebo (Sterile Water for Injection)

Timeline

• Start date: 2006-10-01
• Completion: 2007-08-01
• First posted: 2007-12-04
• Last updated: 2007-12-04

Locations

1 site across 1 country: United States