A Study to Evaluate the Efficacy and Tolerability of Rizatriptan for Treatment of Acute Migraine (0462-087)

Study Overview
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Brief Summary
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A study to provide evidence supporting the benefit of Rizatriptan in patients who have an inadequate response to sumatriptan.

Official Title
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A Multicenter, Randomized, Double-Blind, Placebo-Controlled Crossover Trial to Evaluate the Efficacy and Tolerability of Rizatriptan 10 mg for the Treatment of Acute Migraine in Sumatriptan Non-Responders

Conditions
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Acute Migraine

Intervention / Treatment
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* Drug: rizatriptan
* Drug: Comparator: Placebo
* Drug: Comparator: Sumatriptan


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient has a history of migraine with or without aura for 1 year or more with 2-8 moderate or severe migraine attacks per month Patient generally does not respond to treatment with sumatriptan Patient of reproductive potential agrees to remain abstinent or use one method of highly effective birth control (i.e. IUD, condoms, hormonal contraceptive, diaphragm, vasectomy) for the duration of the study Patient is able to complete paper diary Exclusion Criteria: Patient is pregnant or breast feeding or excepts to become pregnant during the study Patient has history of mild migraine attacks or migraines that usually resolve spontaneously in less than 2 hours Patient has basilar or hemiplegic migraines Patient is unable to distinguish between migraine attacks from other types of headaches Patient has more than 15 headache-days per month Patient was greater than 50 years old at age of migraine onset Patient has failed to respond to 3 or more triptans Patient has a repeated history of failing to respond to or tolerate rizatriptan Patient uses opioids as primary migraine therapy Patient uses daily opioids Patient has a history of Cerebrovascular Accident (CVA) or other significant cardiovascular disease Patient has uncontrolled hypertension Patient has a history of neoplastic disease Patient is taking a serotonin reuptake inhibitor (SSRI or SNRI) where the dose has changed 3 months prior to screening Patient has a history of drug or alcohol abuse

Ages Eligible for Study
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Minimum Age: 18 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: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Sequence A<br>Rizatriptan - Rizatriptan - Placebo | Drug: rizatriptan<br>* Single dose of 10 mg orally disintegrating tablet at onset of migraine attack<br>Drug: Comparator: Placebo<br>* Placebo to Rizatriptan<br>|
| Experimental: Treatment Sequence B<br>Rizatriptan - Placebo - Rizatriptan | Drug: rizatriptan<br>* Single dose of 10 mg orally disintegrating tablet at onset of migraine attack<br>Drug: Comparator: Placebo<br>* Placebo to Rizatriptan<br>|
| Experimental: Treatment Sequence C<br>Placebo - Rizatriptan - Rizatriptan | Drug: rizatriptan<br>* Single dose of 10 mg orally disintegrating tablet at onset of migraine attack<br>Drug: Comparator: Placebo<br>* Placebo to Rizatriptan<br>|
| Other: Baseline Phase<br>Sumatriptan | Drug: Comparator: Sumatriptan<br>* single dose of generic sumatriptan 100 mg at onset of migraine attack<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Relief (PR) | Pain severity was rated by the participants in a paper diary. Pain severity rating scale: 0 (no pain), 1 (mild pain), 2 (moderate pain), or 3 (severe pain). Pain relief (PR) is defined as a reduction in headache severity from Grade 3/2 at baseline to Grade 1/0 post dose. | 2 hours post dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Freedom (PF) | Headache pain severity, relative to the administration of study medication, was rated by the participants in a paper diary. Pain severity rating scale: 0 (no pain), 1 (mild pain), 2 (moderate pain), or 3 (severe pain). Pain freedom (PF) is defined as a reduction in headache severity from Grade 3/2 at baseline to Grade 0 (no pain) post dose. | 2 hours post dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Treatment of acute migraine with or without aura in adults