Treatment of Multiple Attacks of Acute Migraine (0462-025)

Organon

Status and phase: Completed; Phase 3

Conditions: Migraine Headache

Treatments: Drug: Comparator: Placebo; Drug: rizatriptan benzoate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00899379

2009_590

MK0462-025

0462-025

Details and patient eligibility

About

A study to evaluate rizatriptan for the treatment of multiple attacks of acute migraine compared to placebo.

Enrollment: 473 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient had at least a 6-month history of migraine, with or without aura
• Patient was male, or if female must have been postmenopausal, surgically sterilized, or taking adequate contraceptive precautions.
• Patient was judged to be in good health, apart from migraine

Exclusion criteria

• Patient was pregnant or a nursing mother.
• Patient had abused drugs or alcohol within 12 months prior to entering the study
• Patient had a history of cardiovascular disease
• Patient had clinically significant ECG abnormality
• Patient had a resting systolic blood pressure of greater than 145 mm Hg or diastolic of less than 95 mm Hg at screening
• Patient received treatment with an investigational device or compound within 30 days of the study start
• Patient typically suffered from less then 1 or more than 8 attacks of migraine per month
• Patient had difficulty in distinguishing his/her migraine attacks from tension or interval headaches
• Patient had prior exposure to rizatriptan

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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473 participants in 5 patient groups

Treatment Sequence 1

Experimental group

Description:

Placebo-Rizatriptan-Rizatriptan-Rizatriptan

Treatment:

Drug: rizatriptan benzoate

Drug: Comparator: Placebo

Treatment Sequence 2

Experimental group

Description:

Rizatriptan-Placebo-Rizatriptan-Rizatriptan

Treatment:

Drug: rizatriptan benzoate

Drug: Comparator: Placebo

Treatment Sequence 3

Experimental group

Description:

Rizatriptan-Rizatriptan-Placebo-Rizatriptan

Treatment:

Drug: rizatriptan benzoate

Drug: Comparator: Placebo

Treatment Sequence 4

Experimental group

Description:

Rizatriptan-Rizatriptan-Rizatriptan-Placebo

Treatment:

Drug: rizatriptan benzoate

Drug: Comparator: Placebo

Treatment Sequence 5

Experimental group

Description:

Rizatriptan-Rizatriptan-Rizatriptan-Rizatriptan

Treatment:

Drug: rizatriptan benzoate