Phase 3 N=1,268 Randomized Double-blind Treatment

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

Migraine Headache

Bottom Line

View on ClinicalTrials.gov: NCT00898677 ↗

Enrolled (actual)

1,268

Serious AEs

0.1%

Results posted

Jul 2009

Primary outcome: Primary: Pain Relief at 2 Hours After Dose — 99; 258; 239; 64 Participants

Study Design & Population

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

Outcome Measures

Outcome	Result	p-value
PRIMARY Pain Relief at 2 Hours After Dose	99; 258; 239; 64; 65; 127	—
PRIMARY Time to Relief Within 2 Hours After Dose	102; 265; 247; 72; 62; 120	—
SECONDARY Pain Free at 2 Hours After Dose	41; 155; 127; 15; 123; 230	—
SECONDARY Functional Status at 2 Hours After Dose	52; 160; 126; 31; 62; 123	—
SECONDARY Nausea at 2 Hours After Dose	37; 95; 128; 68; 127; 290	—

Summary

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.

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 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

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Data sourced from ClinicalTrials.gov (NCT00898677). 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.