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

February 1, 2022 updated by: Organon and Co

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Crossover Trial to Evaluate the Efficacy and Tolerability of Rizatriptan 10 mg ODT for the Treatment of Acute Migraine in Patients on Topiramate for Migraine Prophylaxis

This study will provide additional efficacy data for rizatriptan when used for an acute migraine attack in patients already taking topiramate for migraine prophylaxis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

108

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
Treatment Sequence A: rizatriptan, rizatriptan, placebo
Drug: rizatriptan benzoate
rizatriptan 10 mg Orally Disintegrating Tablet (ODT) orally for a moderate or severe migraine attack
Other Names:
  • Maxalt
Drug: Comparator: placebo
Placebo to rizatriptan 10 mg ODT orally for a moderate or severe migraine attack
Experimental: B
Sequence B: rizatriptan, placebo, rizatriptan
Drug: rizatriptan benzoate
rizatriptan 10 mg Orally Disintegrating Tablet (ODT) orally for a moderate or severe migraine attack
Other Names:
  • Maxalt
Drug: Comparator: placebo
Placebo to rizatriptan 10 mg ODT orally for a moderate or severe migraine attack
Experimental: C
Sequence C: placebo, rizatriptan, rizatriptan
Drug: rizatriptan benzoate
rizatriptan 10 mg Orally Disintegrating Tablet (ODT) orally for a moderate or severe migraine attack
Other Names:
  • Maxalt
Drug: Comparator: placebo
Placebo to rizatriptan 10 mg ODT orally for a moderate or severe migraine attack

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Relief (PR)
Time Frame: 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.
2 hours post dose

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sustained Pain Relief (SPR)
Time Frame: 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.
2 - 24 hours post dose
Pain Freedom (PF)
Time Frame: 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.
2 hours post dose
Normal Rating of Functional Disability (NRFD)
Time Frame: 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.
2 hours post dose
Treatment Satisfaction (TS)
Time Frame: 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.
24 hours post dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Organon and Co

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 24, 2009

Primary Completion (Actual)

October 22, 2009

Study Completion (Actual)

October 22, 2009

Study Registration Dates

First Submitted

December 17, 2008

First Submitted That Met QC Criteria

December 17, 2008

First Posted (Estimate)

December 19, 2008

Study Record Updates

Last Update Posted (Actual)

February 22, 2022

Last Update Submitted That Met QC Criteria

February 1, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0462-085
  • 2008_597

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf

http://engagezone.msd.com/ds_documentation.php

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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