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Phase 3 N=194 Randomized Double-blind Treatment

A Study to Evaluate the Efficacy and Tolerability of Rizatriptan for Treatment of Acute Migraine (0462-087)

Acute Migraine

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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

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