Rizatriptan 5 mg and 10 mg, Sumatriptan 100 mg, and Placebo Comparison Study (0462-030)

Condition(s) targeted: Migraine Headache

Intervention: rizatriptan benzoate (Drug); rizatriptan benzoate (Drug); Comparator: sumatriptan (Drug); Comparator: Placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Merck Sharp & Dohme Corp.

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck Sharp & Dohme Corp.

A study to compare rizatriptan 10 mg verse sumatriptan 100 mg in the treatment of migraine attacks and duration of relief provided. This study will also provide additional efficacy data on rizatriptan 5 mg and 10 mg for the treatment of migraine.

Official title: A Randomized, Placebo-Controlled, Parallel-Groups, Outpatient Study to Examine the Safety, Tolerability, and Efficacy of Single Oral Doses of MK0462 5 mg, MK0462 10 mg, and Sumatriptan 100 mg for Acute Treatment of Migraine

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome:

Pain Relief at 2 Hours After Dose

Time to Relief Within 2 Hours After Dose

Secondary outcome:

Pain Free at 2 Hours After Dose

Functional Status at 2 Hours After Dose

Nausea at 2 Hours After Dose

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

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 Electrocardiography (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 hypersensitivity to sumatriptan

- Patient had participated in any previous study involving rizatriptan

MedWatch - FDA maintained medical product safety Information

Merck: Patient & Caregiver U.S. Product Web Site

Related publications:

Ho TW, Rodgers A, Bigal ME. Impact of recent prior opioid use on rizatriptan efficacy. A post hoc pooled analysis. Headache. 2009 Mar;49(3):395-403. doi: 10.1111/j.1526-4610.2009.01346.x. Epub 2008 Feb 12.

Starting date: September 1995
Last updated: February 13, 2015