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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00812006
First received: December 17, 2008
Last updated: September 4, 2014
Last verified: September 2014
  Purpose

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 Intervention Phase
Migraine
Drug: rizatriptan benzoate
Drug: Comparator: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Pain Relief (PR) [ Time Frame: 2 hours post dose ] [ Designated as safety issue: No ]
    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) [ Time Frame: 2 - 24 hours post dose ] [ Designated as safety issue: No ]
    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) [ Time Frame: 2 hours post dose ] [ Designated as safety issue: No ]
    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) [ Time Frame: 2 hours post dose ] [ Designated as safety issue: No ]
    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) [ Time Frame: 24 hours post dose ] [ Designated as safety issue: No ]
    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.


Enrollment: 108
Study Start Date: March 2009
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00812006

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

Additional Information:
Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00812006     History of Changes
Other Study ID Numbers: 0462-085, 2008_597
Study First Received: December 17, 2008
Results First Received: September 23, 2010
Last Updated: September 4, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Migraine Disorders
Brain Diseases
Central Nervous System Diseases
Headache Disorders
Headache Disorders, Primary
Nervous System Diseases
Rizatriptan
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Serotonin Agents
Serotonin Receptor Agonists

ClinicalTrials.gov processed this record on October 23, 2014