Phase 3 N=1,473 Randomized Double-blind Treatment

MK0462 in Treatment of Migraine With Recurrence (MK0462-022)

Migraine Headache

Bottom Line

View on ClinicalTrials.gov: NCT00897949 ↗

Enrolled (actual)

1,473

Serious AEs

0.3%

Results posted

May 2011

Primary outcome: Primary: Pain Relief at 2 Hours After the Initial Dose of Test Drug — 285; 322; 106; 172 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: rizatriptan benzoate (MK0462) (Drug); Comparator: placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Organon and Co
Primary completion: Jan 1996

Outcome Measures

Outcome	Result	p-value
PRIMARY Pain Relief at 2 Hours After the Initial Dose of Test Drug	285; 322; 106; 172; 133; 196	—
SECONDARY Pain Free at 2 Hours After the Initial Dose of Test Drug	150; 193; 30; 307; 262; 272	—
SECONDARY No Disability at 2 Hours After the Initial Dose of Test Drug	175; 209; 54; 160; 148; 118	—
SECONDARY Use of Escape Medication at 2 Hours After the Initial Dose of Test Drug	101; 76; 128; 357; 380; 176	—
SECONDARY Pain Relief 2 Hours After Treatment for Headache Recurrence	39; 32; 53; 33; 12; 18	—

Summary

A study to evaluate rizatriptan/MK0462 (5 and 10 mg) for the treatment of acute migraine attack and treatment of up to two headache recurrences compared to placebo. The long term extension study which pools patients from MK0462-022, -025, and -029 is described in NCT01286207.

Eligibility 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 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

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Data sourced from ClinicalTrials.gov (NCT00897949). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.