Phase 3
N=933
MK0462 5 mg, Sumatriptan 50 mg, and Placebo Comparison Study (0462-029)
Migraine Headache
Bottom Line
View on ClinicalTrials.gov: NCT00897104 ↗Enrolled (actual)
933
Serious AEs
0.0%
Results posted
Jul 2010
Primary outcome: Primary: Pain Relief at 2 Hours After Treatment — 223; 238; 18; 129 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- rizatriptan benzoate (MK0462) (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 Treatment |
223; 238; 18; 129; 118; 62 | — |
| PRIMARY Time to Relief Within 2 Hours After Treatment |
231; 247; 24; 121; 109; 56 | — |
| SECONDARY Pain Free at 2 Hours After Treatment |
95; 113; 2; 257; 243; 78 | — |
| SECONDARY Lack of Functional Disability at 2 Hours After Treatment as Measured by the Level of Impairment in Daily Activities |
108; 116; 4; 152; 148; 28 | — |
| SECONDARY Presence or Absence of Associated Symptoms (Photophobia, Phonophobia, Nausea, and Vomiting) at 2 Hours After Treatment |
161; 153; 66; 189; 201; 14 | — |
| SECONDARY Participants Who Used Escape Medication 2 Hours After the Treatment Dose |
73; 55; 33; 282; 302; 47 | — |
| SECONDARY Duration of Relief (Time to Recurrence From the Time of First Recorded Pain Relief [Grade = 0 or 1]) |
11.07; 11.58; 14.38 | — |
Summary
A study to compare rizatriptan (MK0462) 5 mg by mouth (p.o.) and sumatriptan 50 mg p.o. for the acute treatment of a migraine attack.
Eligibility Criteria
Inclusion Criteria
- Participant had at least a 6-month history of migraine, with or without aura
- Participant was male, or if female, must have been postmenopausal, surgically sterilized, or taking adequate contraceptive precautions
- Participant was judged to be in good health, apart from migraine
Exclusion Criteria
- Participant was Pregnant or a nursing mother
- Participant had a history or current evidence of drug or alcohol abuse
- Participant had a history or clinical evidence of cardiovascular disease
- Participant had a clinically significant Electrocardiography (ECG) abnormality
- Participant had a resting systolic blood pressure of greater than 145 mm Hg or diastolic of less than 95 mm Hg at screening
- Participant had received treatment with an investigational device or compound within 30 days of the study
- Participant typically suffered from less then 1 or more than 8 attacks of migraine per month
- Participant had difficulty in distinguishing his/her migraine attacks from tension or interval headaches
- Participant was currently taking monoamine oxidase inhibitors, methysergide or lithium
Data sourced from ClinicalTrials.gov (NCT00897104). 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.