Phase 3
Completed N=108
A Study of Rizatriptan for the Treatment of Acute Migraine in Patients on Topiramate for Migraine Prophylaxis
Source: ClinicalTrials.gov NCT00812006 ↗Enrolled (actual)
108
Serious AEs
0.0%
Results posted
Jan 2011
Primary outcomePrimary: Pain Relief (PR) — 105; 21; 88; 72 Attacks — p=<0.001
Summary
This study will provide additional efficacy data for rizatriptan when used for an acute migraine attack in patients already taking topiramate for migraine prophylaxis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain Relief (PR) |
105; 21; 88; 72 | <0.001 sig |
| SECONDARY Sustained Pain Relief (SPR) |
67; 12; 126; 81 | <0.001 sig |
| SECONDARY Pain Freedom (PF) |
74; 9; 119; 84 | <0.001 sig |
| SECONDARY Normal Rating of Functional Disability (NRFD) |
85; 16; 108; 77 | <0.001 sig |
| SECONDARY Treatment Satisfaction (TS) |
117; 31; 76; 62 | <0.001 sig |
Eligibility Criteria
Inclusion Criteria
- Patient has a history of migraine with or without aura for more than one year, with between 2 and 8 moderate to severe attacks per month
- Patient is currently taking at least 50 mg topiramate daily for migraine prophylaxis
- Patient can distinguish between migraine and other types of headache
- Patient agrees to remain abstinent or use effective birth control during the study
Exclusion Criteria
- Patient is pregnant or breast-feeding
- Patient has a history of mostly mild migraines or migraines that resolve within 2 hours
- Patient has more than 15 headache-days per month or has taken medication for acute headache on more than 10 days per month in the 3 months prior to screening.
- Patient was > 50 years old at age of migraine onset
- Patient has history of heart disease
- Patient has uncontrolled hypertension
- Patient has had cancer within 5 years of screening (excepting certain skin and cervical cancers)
- Patient has started taking Selective Serotonin Reuptake Inhibitors (SSRIs) or Serotonin-Norepinephrine Reuptake Inhibitors (SNRIs) or has changed doses within 3 months of screening
- Patient is taking more than one other migraine prophylactic medication
- Patient has repeatedly failed to respond to or tolerate rizatriptan
Data sourced from ClinicalTrials.gov (NCT00812006). 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. Informational only — not medical advice.