A Study of Rizatriptan for the Treatment of Acute Migraine in Patients on Topiramate for Migraine Prophylaxis

Phase 3

Completed

• Conditions: Migraine
• Interventions: Drug: rizatriptan benzoate

• Registration Number: NCT00812006
• Lead Sponsor: Organon and Co

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-12-17
• Study First Submitted QC: 2008-12-17
• Study First Posted: 2008-12-19
• Study Start: 2009-03-24
• Primary Completion: 2009-10-22
• Study Completion: 2009-10-22
• Results First Submitted: 2010-09-23
• Results First Submitted QC: 2011-01-26
• Results First Posted: 2011-01-27
• Status Verified: 2022-02
• Last Update Submitted: 2024-05-09
• Last Update Posted: 2024-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 108

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
A	rizatriptan benzoate	Treatment Sequence A: rizatriptan, rizatriptan, placebo
B	rizatriptan benzoate	Sequence B: rizatriptan, placebo, rizatriptan
C	rizatriptan benzoate	Sequence C: placebo, rizatriptan, rizatriptan

Primary Outcome Measures

Name	Time	Method
Pain Relief (PR)	2 hours post dose	Pain severity was rated by the participants in a paper diary. Pain severity rating scale : 0 (no pain), 1 (mild pain), 2 (moderate pain), or 3 (severe pain). Pain relief (PR) is defined as a reduction in headache severity from Grade 3/2 at baseline to Grade 1/0 post dose.

Secondary Outcome Measures

Name	Time	Method
Pain Freedom (PF)	2 hours post dose	Headache pain severity, relative to the administration of study medication, was rated by the participants in a paper diary. Pain severity rating scale: 0 (no pain), 1 (mild pain), 2 (moderate pain), or 3 (severe pain). Pain freedom (PF) is defined as a reduction in headache severity from Grade 3/2 at baseline to Grade 0 (no pain) post dose.
Sustained Pain Relief (SPR)	2 - 24 hours post dose	24-hour sustained pain relief (defined as pain relief at 2 hours post dose, with no administration of any rescue medication and with no occurrence of a moderate/severe headache during the respective period after dosing with the blinded study medication.
Normal Rating of Functional Disability (NRFD)	2 hours post dose	Level of functional disability was assessed on a paper diary by the participants. Level of functional disability was rated as: normal, mildly impaired, severely impaired, or unable to do activities, requires bedrest. Functional disability ratings was dichotomized to Normal and Not Normal (mildly impaired, severely impaired, or unable to do activities, requires bedrest) for analysis.
Treatment Satisfaction (TS)	24 hours post dose	Patient satisfaction was assessed on a paper diary by the participants. Level of satisfaction was rated as: completely satisfied, very satisfied, somewhat satisfied, neither satisfied nor dissatisfied, somewhat dissatisfied, very dissatisfied, or completely dissatisfied. The overall 24-hour assessment of study medication was dichotomized to Satisfaction (completely satisfied, very satisfied, somewhat satisfied) and Non-satisfaction (neither satisfied nor dissatisfied, somewhat dissatisfied, very dissatisfied, or completely dissatisfied) for analysis.