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

Organon

Status and phase: Completed; Phase 3

Conditions: Acute Migraine

Treatments: Drug: Comparator: Placebo; Drug: rizatriptan; Drug: Comparator: Sumatriptan

Study type: Interventional

Funder types: Industry

Identifiers

NCT00894556

0462-087

2009_587

Details and patient eligibility

About

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

Enrollment: 109 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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109 participants in 4 patient groups

Treatment Sequence A

Experimental group

Description:

Rizatriptan - Rizatriptan - Placebo

Treatment:

Drug: rizatriptan

Drug: Comparator: Placebo

Treatment Sequence B

Experimental group

Description:

Rizatriptan - Placebo - Rizatriptan

Treatment:

Drug: rizatriptan

Drug: Comparator: Placebo

Treatment Sequence C

Experimental group

Description:

Placebo - Rizatriptan - Rizatriptan

Treatment:

Drug: rizatriptan

Drug: Comparator: Placebo

Baseline Phase

Other group

Description:

Sumatriptan

Treatment:

Drug: Comparator: Sumatriptan