Phase 3
N=194
A Study to Evaluate the Efficacy and Tolerability of Rizatriptan for Treatment of Acute Migraine (0462-087)
Acute Migraine
Bottom Line
View on ClinicalTrials.gov: NCT00894556 ↗Enrolled (actual)
194
Serious AEs
0.0%
Results posted
Jan 2011
Primary outcome: Primary: Pain Relief (PR) — 102; 21; 100; 78 attacks — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- rizatriptan (Drug); Comparator: Placebo (Drug); Comparator: Sumatriptan (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Organon and Co
- Primary completion
- Jan 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain Relief (PR) |
102; 21; 100; 78 | <0.001 sig |
| SECONDARY Pain Freedom (PF) |
46; 12; 156; 87 | <0.001 sig |
Summary
A study to provide evidence supporting the benefit of Rizatriptan in patients who have an inadequate response to sumatriptan.
Eligibility Criteria
Inclusion Criteria
- Patient has a history of migraine with or without aura for 1 year or more with 2-8 moderate or severe migraine attacks per month
- Patient generally does not respond to treatment with sumatriptan
- Patient of reproductive potential agrees to remain abstinent or use one method of highly effective birth control (i.e. IUD, condoms, hormonal contraceptive, diaphragm, vasectomy) for the duration of the study
- Patient is able to complete paper diary
Exclusion Criteria
- Patient is pregnant or breast feeding or excepts to become pregnant during the study
- Patient has history of mild migraine attacks or migraines that usually resolve spontaneously in less than 2 hours
- Patient has basilar or hemiplegic migraines
- Patient is unable to distinguish between migraine attacks from other types of headaches
- Patient has more than 15 headache-days per month
- Patient was greater than 50 years old at age of migraine onset
- Patient has failed to respond to 3 or more triptans
- Patient has a repeated history of failing to respond to or tolerate rizatriptan
- Patient uses opioids as primary migraine therapy
- Patient uses daily opioids
- Patient has a history of Cerebrovascular Accident (CVA) or other significant cardiovascular disease
- Patient has uncontrolled hypertension
- Patient has a history of neoplastic disease
- Patient is taking a serotonin reuptake inhibitor (SSRI or SNRI) where the dose has changed 3 months prior to screening
- Patient has a history of drug or alcohol abuse
Data sourced from ClinicalTrials.gov (NCT00894556). 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.