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

Primary Purpose

Migraine

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
rizatriptan benzoate
Comparator: placebo
Sponsored by
Organon and Co
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Experimental

    Arm Label

    A

    B

    C

    Arm Description

    Treatment Sequence A: rizatriptan, rizatriptan, placebo

    Sequence B: rizatriptan, placebo, rizatriptan

    Sequence C: placebo, rizatriptan, rizatriptan

    Outcomes

    Primary Outcome Measures

    Pain Relief (PR)
    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

    Sustained Pain Relief (SPR)
    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.
    Pain Freedom (PF)
    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.
    Normal Rating of Functional Disability (NRFD)
    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)
    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.

    Full Information

    First Posted
    December 17, 2008
    Last Updated
    February 1, 2022
    Sponsor
    Organon and Co
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00812006
    Brief Title
    A Study of Rizatriptan for the Treatment of Acute Migraine in Patients on Topiramate for Migraine Prophylaxis
    Official Title
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    March 24, 2009 (Actual)
    Primary Completion Date
    October 22, 2009 (Actual)
    Study Completion Date
    October 22, 2009 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Organon and Co

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Migraine

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    108 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    A
    Arm Type
    Experimental
    Arm Description
    Treatment Sequence A: rizatriptan, rizatriptan, placebo
    Arm Title
    B
    Arm Type
    Experimental
    Arm Description
    Sequence B: rizatriptan, placebo, rizatriptan
    Arm Title
    C
    Arm Type
    Experimental
    Arm Description
    Sequence C: placebo, rizatriptan, rizatriptan
    Intervention Type
    Drug
    Intervention Name(s)
    rizatriptan benzoate
    Other Intervention Name(s)
    Maxalt
    Intervention Description
    rizatriptan 10 mg Orally Disintegrating Tablet (ODT) orally for a moderate or severe migraine attack
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator: placebo
    Intervention Description
    Placebo to rizatriptan 10 mg ODT orally for a moderate or severe migraine attack
    Primary Outcome Measure Information:
    Title
    Pain Relief (PR)
    Description
    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.
    Time Frame
    2 hours post dose
    Secondary Outcome Measure Information:
    Title
    Sustained Pain Relief (SPR)
    Description
    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.
    Time Frame
    2 - 24 hours post dose
    Title
    Pain Freedom (PF)
    Description
    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.
    Time Frame
    2 hours post dose
    Title
    Normal Rating of Functional Disability (NRFD)
    Description
    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.
    Time Frame
    2 hours post dose
    Title
    Treatment Satisfaction (TS)
    Description
    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.
    Time Frame
    24 hours post dose

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Monitor
    Organizational Affiliation
    Merck Sharp & Dohme LLC
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing 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
    Citations:
    PubMed Identifier
    22078129
    Citation
    Seeburger JL, Cady RK, Winner P, MacGregor A, Valade D, Ge Y, Zhang Y, Hustad CM, Strickler N, Schaefer E, Connor KM, Ho TW. Rizatriptan for treatment of acute migraine in patients taking topiramate for migraine prophylaxis. Headache. 2012 Jan;52(1):57-67. doi: 10.1111/j.1526-4610.2011.02027.x. Epub 2011 Nov 11.
    Results Reference
    result

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

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