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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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ClinicalTrials.gov Identifier: NCT00812006
Recruitment Status : Completed
First Posted : December 19, 2008
Results First Posted : January 27, 2011
Last Update Posted : June 6, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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.

Condition or disease Intervention/treatment Phase
Migraine Drug: rizatriptan benzoate Drug: Comparator: placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : March 24, 2009
Primary Completion Date : October 22, 2009
Study Completion Date : October 22, 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine
U.S. FDA Resources

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 Name: 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 Name: 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 Name: Maxalt
Drug: Comparator: placebo
Placebo to rizatriptan 10 mg ODT orally for a moderate or severe migraine attack



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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. 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.

  3. 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.

  4. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00812006


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.

Additional Information:
Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00812006     History of Changes
Other Study ID Numbers: 0462-085
2008_597
First Posted: December 19, 2008    Key Record Dates
Results First Posted: January 27, 2011
Last Update Posted: June 6, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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


Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Topiramate
Rizatriptan
Anticonvulsants
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs
Anti-Obesity Agents
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action