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

Organon

Status and phase: Completed; Phase 3

Conditions: Migraine

Treatments: Drug: Comparator: placebo; Drug: rizatriptan benzoate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00812006

0462-085

2008_597

Details and patient eligibility

About

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

Enrollment: 108 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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108 participants in 3 patient groups

A

Experimental group

Description:

Treatment Sequence A: rizatriptan, rizatriptan, placebo

Treatment:

Drug: Comparator: placebo

Drug: rizatriptan benzoate

B

Experimental group

Description:

Sequence B: rizatriptan, placebo, rizatriptan

Treatment:

Drug: Comparator: placebo

Drug: rizatriptan benzoate

C

Experimental group

Description:

Sequence C: placebo, rizatriptan, rizatriptan

Treatment:

Drug: Comparator: placebo

Drug: rizatriptan benzoate