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

Study Overview
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Brief Summary
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Evaluation of headache response at 2 hours for active treated attacks for increasing dose.

Official Title
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A Multicentre, Dose Optimisation Study to Assess the Consistency of Efficacy of Eletriptan for the Treatment of Migraine (With and Without Aura)

Conditions
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Migraine Without Aura, Migraine With Aura

Intervention / Treatment
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* Drug: Placebo
* Drug: Eletriptan HBr 40 mg
* Drug: Eletriptan HBr 80 mg


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* 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.<br>|
| Experimental: Eletriptan HBr 40 mg<br> | Drug: Eletriptan HBr 40 mg<br>* 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.<br>|
| Experimental: Eletriptan HBr 80 mg<br> | Drug: Eletriptan HBr 80 mg<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Consistency of headache response (3 responses out of 3 active treated attacks) . Headache response was defined as migraine headache pain of moderate or severe intensity pre dose becoming basent or mild within 2 hours post dose. |  | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Consistency of headache response (2 responses out of 3 active treated attacks). Headache response was defined as migraine headache pain of moderate or severe intensity pre dose becoming basent or mild within 2 hours post dose. |  | 24 weeks |