A Study of Rizatriptan for the Treatment of Acute Migraine in Patients on Topiramate for Migraine Prophylaxis

Study Overview
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Brief Summary
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This study will provide additional efficacy data for rizatriptan when used for an acute migraine attack in patients already taking topiramate for migraine prophylaxis.

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 ODT for the Treatment of Acute Migraine in Patients on Topiramate for Migraine Prophylaxis

Conditions
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Migraine

Intervention / Treatment
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* Drug: rizatriptan benzoate
* Drug: Comparator: placebo


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 more than one year, with between 2 and 8 moderate to severe attacks per month Patient is currently taking at least 50 mg topiramate daily for migraine prophylaxis Patient can distinguish between migraine and other types of headache Patient agrees to remain abstinent or use effective birth control during the study Exclusion Criteria: Patient is pregnant or breast-feeding Patient has a history of mostly mild migraines or migraines that resolve within 2 hours Patient has more than 15 headache-days per month or has taken medication for acute headache on more than 10 days per month in the 3 months prior to screening. Patient was > 50 years old at age of migraine onset Patient has history of heart disease Patient has uncontrolled hypertension Patient has had cancer within 5 years of screening (excepting certain skin and cervical cancers) Patient has started taking Selective Serotonin Reuptake Inhibitors (SSRIs) or Serotonin-Norepinephrine Reuptake Inhibitors (SNRIs) or has changed doses within 3 months of screening Patient is taking more than one other migraine prophylactic medication Patient has repeatedly failed to respond to or tolerate rizatriptan

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: A<br>Treatment Sequence A: rizatriptan, rizatriptan, placebo | Drug: rizatriptan benzoate<br>* rizatriptan 10 mg Orally Disintegrating Tablet (ODT) orally for a moderate or severe migraine attack<br>* Other names: Maxalt;Drug: Comparator: placebo<br>* Placebo to rizatriptan 10 mg ODT orally for a moderate or severe migraine attack<br>|
| Experimental: B<br>Sequence B: rizatriptan, placebo, rizatriptan | Drug: rizatriptan benzoate<br>* rizatriptan 10 mg Orally Disintegrating Tablet (ODT) orally for a moderate or severe migraine attack<br>* Other names: Maxalt;Drug: Comparator: placebo<br>* Placebo to rizatriptan 10 mg ODT orally for a moderate or severe migraine attack<br>|
| Experimental: C<br>Sequence C: placebo, rizatriptan, rizatriptan | Drug: rizatriptan benzoate<br>* rizatriptan 10 mg Orally Disintegrating Tablet (ODT) orally for a moderate or severe migraine attack<br>* Other names: Maxalt;Drug: Comparator: placebo<br>* Placebo to rizatriptan 10 mg ODT orally for a moderate or severe 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 |
| --- | --- | --- |
| Sustained Pain Relief (SPR) | 24-hour sustained pain relief (defined as pain relief at 2 hours post dose, with no administration of any rescue medication and with no occurrence of a moderate/severe headache during the respective period after dosing with the blinded study medication. | 2 - 24 hours post dose | 
| 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 | 
| Normal Rating of Functional Disability (NRFD) | Level of functional disability was assessed on a paper diary by the participants. Level of functional disability was rated as: normal, mildly impaired, severely impaired, or unable to do activities, requires bedrest. Functional disability ratings was dichotomized to Normal and Not Normal (mildly impaired, severely impaired, or unable to do activities, requires bedrest) for analysis. | 2 hours post dose | 
| Treatment Satisfaction (TS) | Patient satisfaction was assessed on a paper diary by the participants. Level of satisfaction was rated as: completely satisfied, very satisfied, somewhat satisfied, neither satisfied nor dissatisfied, somewhat dissatisfied, very dissatisfied, or completely dissatisfied. The overall 24-hour assessment of study medication was dichotomized to Satisfaction (completely satisfied, very satisfied, somewhat satisfied) and Non-satisfaction (neither satisfied nor dissatisfied, somewhat dissatisfied, very dissatisfied, or completely dissatisfied) for analysis. | 24 hours post dose |