Migraine
Conditions
Keywords
Migraine
Brief 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
Interventions
DRUGTEZAMPANEL
Single Administration of: TEZAMPANEL 40 mg; TEZAMPANEL 70 mg; TEZAMPANEL 100 mg; Placebo (Sterile Water for Injection)
Sponsors
TorreyPines Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Patients who meet all of the following inclusion criteria at screening should be considered for admission to the study: 1. Males and females aged 18 to 65 years, inclusive. a. Females of childbearing potential must not be at risk for pregnancy during the study. 2. Patients must meet IHS diagnostic criteria for migraine, with or without aura. 3. Patients should have a history of 1 to 6 acute migraine headache attacks per month and 1 migraine headache within the past 30 days. 4. Patients should have at least a 1-year history of migraine headaches. 5. Patients should have been ≤ 50 years of age at initial migraine onset. 6. Patients must be able to distinguish migraine headaches as discreet headaches from other headaches, such as tension-type headaches. Additionally, patients should experience at least 48 hours of freedom from headaches between migraine attacks. 7. Patients must have a complete medical history (including headache history), ECG, and a PE at screening including formal assessments of visual acuity (Snellen chart) and visual field integrity visit. 8. Patients must be able to comprehend and satisfactorily comply with the protocol requirements, in the opinion of the investigator.
Exclusion criteria
* Patients who meet any of the following
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Headache pain intensity, associated symptoms, functional response questionnaires, time to meaningful pain relief. | 4 Hours |
Countries
United States
Outcome results
None listed