Eletriptan Provides Consistent Migraine Relief: Results Of A Within-Patient Multiple-Dose Study

• Migraine Without Aura
• Migraine With Aura

• Drug: Placebo
  
  All subjects will receive open label eletriptan 40 mg per attack for the first three attacks in the phase 1 of the study. For the next 4 attacks subjects will be assigned to either eletriptan 40 mg or 80 mg group based on the response in the phase 1 portion of the study. In phase II, in each group subjects will receive eletriptan 40 mg or 80 mg for 3 attacks and placebo for 1 attack. In each group double-blind placebo will be inserted at random.
• Drug: Eletriptan HBr 40 mg
  
  All subjects will receive open label eletriptan 40 mg per attack for the first three attacks in the phase 1 of the study. For the next 4 attacks subjects will be assigned to either eletriptan 40 mg or 80 mg group based on the response in the phase 1 portion of the study. In phase II, in each group subjects will receive eletriptan 40 mg or 80 mg for 3 attacks and placebo for 1 attack. In each group double-blind placebo will be inserted at random.
• Drug: Eletriptan HBr 80 mg
  
  All subjects will receive open label eletriptan 40 mg per attack for the first three attacks in the phase 1 of the study. For the next 4 attacks subjects will be assigned to either eletriptan 40 mg or 80 mg group based on the response in the phase 1 portion of the study. In phase II, in each group subjects will receive eletriptan 40 mg or 80 mg for 3 attacks and placebo for 1 attack. In each group double-blind placebo will be inserted at random.

• Placebo Comparator: Placebo
  
  Intervention: Drug: Placebo
• Experimental: Eletriptan HBr 40 mg
  
  Intervention: Drug: Eletriptan HBr 40 mg
• Experimental: Eletriptan HBr 80 mg
  
  Intervention: Drug: Eletriptan HBr 80 mg

Inclusion Criteria:

• Male and Female subjects in good general health, aged 18 to 65 years.
• Subjects should meet IHS diagnostic criteria for migraine with or without aura.
• Based on past history, subjects should expect to suffer at least one acute attack of migraine with or without aura, each 6 weeks

Exclusion Criteria:

• Known coronary-artery disease, clinically significant arrhythmia, heart failure, or uncontrolled hypertension.
• Pregnant or lactating women.
• Clinically significant electrocardiogram abnormalities at screening.