A Study of Rizatriptan for the Treatment of Acute Migraine in Patients on Topiramate for Migraine Prophylaxis - Full Text View

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:

Genetics Home Reference related topics: familial hemiplegic migraine

MedlinePlus related topics: Migraine

Drug Information available for: Potassium benzoate Topiramate Rizatriptan Rizatriptan benzoate

U.S. FDA Resources

Further study details as provided by Merck:

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

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

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Additional Information:

MedWatch - FDA maintained medical product safety Information This link exits the ClinicalTrials.gov site

Merck: Patient & Caregiver U.S. Product Web Site This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	VP Late Stage Development, Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:	NCT00812006 History of Changes
Other Study ID Numbers:	MK-0462-085, 2008_597
Study First Received:	December 17, 2008
Results First Received:	September 23, 2010
Last Updated:	January 26, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Benzoates
Topiramate
Rizatriptan
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses

Pharmacologic Actions
Anticonvulsants
Central Nervous System Agents
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs
Anti-Obesity Agents
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2013