Eletriptan for the Treatment of Migraine in Patients With Previous Poor Response or Tolerance to Oral Sumatriptan

Study Overview
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Brief Summary
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To determine the tolerability and efficacy of eletriptan in patients who had discontinued oral sumatriptan due to lack of efficacy or intolerable adverse events (AEs) during previous clinical treatment (not a controlled trial).

Official Title
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A Multicenter, Double - Blind, Randomized, Placebo - Controlled Parallel Group Study of the Efficacy and Safety of Oral Eletriptan (40 and 80mg) Given for the Treatment of Acute Migraine in Subjects Discontinued From Oral Sumatriptan

Conditions
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Migraine With or Without Aura

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female subjects age ≥ 18 years who met the International Headache Society (IHS) diagnostic criteria for migraine, with or without aura, and could reasonably expect to suffer at least one acute attack of migraine every 6 weeks. Subjects required to have discontinued therapy with oral sumatriptan at least 2 weeks, but not longer than 2 years, prior to the screening visit. Female subjects required to be adequately protected against pregnancy. Exclusion Criteria: pregnancy or breastfeeding, known coronary artery disease, significant arrhythmias, heart failure, significant ECG abnormalities, and uncontrolled hypertension. Any significant systemic, organ, neurological, endocrine, metabolic, and psychological disorders reported by the patient or discovered during the physical examination Subjects considered to have atypical migraine such as frequent attacks, prolonged aura or any migraine that was considered atypical. Subjects who, during the course of the trial, required treatment with sumatriptan or any other 5-HT1B/1D agonist in addition to study medication.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 68 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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>* Subjects were randomized to one of the 3 treatment groups (eletriptan 40 mg, eletriptan 80 mg, or placebo) in a 2:2:1 ratio and were given sufficient medication to treat 3 migraine attacks (including a second dose for each attack for recurrence) within 18 weeks of the initial visit. Subjects were instructed to treat a moderate to severe migraine within 6 hours of the onset of pain provided the headache was not decreasing in severity, the aura phase had ended and they had taken no analgesic or antiemetic within 6 hours. Efficacy data was collected in a diary. Subjects were allowed to take rescue medication if they had no response to the study medication within 4 hours of onset.<br>|
| Experimental: Eletriptan 40 mg<br> | Drug: Eletriptan 40 mg<br>* Subjects were randomized to one of the 3 treatment groups (eletriptan 40 mg, eletriptan 80 mg, or placebo) in a 2:2:1 ratio and were given sufficient medication to treat 3 migraine attacks (including a second dose for each attack for recurrence) within 18 weeks of the initial visit. Subjects were instructed to treat a moderate to severe migraine within 6 hours of the onset of pain provided the headache was not decreasing in severity, the aura phase had ended and they had taken no analgesic or antiemetic within 6 hours. Efficacy data was collected in a diary. Subjects were allowed to take rescue medication if they had no response to the study medication within 4 hours of onset.<br>|
| Experimental: Eletriptan 80 mg<br> | Drug: Eletriptan 80 mg<br>* Subjects were randomized to one of the 3 treatment groups (eletriptan 40 mg, eletriptan 80 mg, or placebo) in a 2:2:1 ratio and were given sufficient medication to treat 3 migraine attacks (including a second dose for each attack for recurrence) within 18 weeks of the initial visit. Subjects were instructed to treat a moderate to severe migraine within 6 hours of the onset of pain provided the headache was not decreasing in severity, the aura phase had ended and they had taken no analgesic or antiemetic within 6 hours. Efficacy data was collected in a diary. Subjects were allowed to take rescue medication if they had no response to the study medication within 4 hours of onset.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary efficacy endpoint was 2-h headache response after taking the first dose of study medication for the first attack | Subjects recorded the intensity of each migraine headache in the diary based on a 4-point scale: 0, pain absent; 1, mild pain; 2, moderate pain; 3, severe pain. A response was considered a change from severe or moderate pain to mild or absent at various time points after dosing with study medication | 18 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sustained response was defined as achieving a headache response within 2 h post dose, with no recurrence or rescue medication needed | Recurrence was defined as a return of headache to moderate or severe intensity within 2-24 h if the subject had an initial response within 2 h of taking the study medication. | 18 weeks |