Phase 3 N=473 Randomized Double-blind Treatment

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

Migraine Headache

Bottom Line

View on ClinicalTrials.gov: NCT00899379 ↗

Enrolled (actual)

473

Serious AEs

0.0%

Results posted

Jul 2010

Primary outcome: Primary: Pain Relief at 2 Hours During the First Migraine Attack Period — 246; 30; 74; 52 participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: rizatriptan benzoate (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 During the First Migraine Attack Period	246; 30; 74; 52	—
SECONDARY Pain Relief at 2 Hours During the Second Migraine Attack Period	228; 27; 63; 46	—
SECONDARY Pain Relief at 2 Hours During the Third Migraine Attack Period	207; 21; 52; 54	—
SECONDARY Pain Relief at 2 Hours During the Fourth Migraine Attack Period	190; 31; 65; 26	—

Summary

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

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00899379). 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.