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A Study to Evaluate the Efficacy and Tolerability of Rizatriptan for Treatment of Acute Migraine (0462-087)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00894556
Recruitment Status : Completed
First Posted : May 7, 2009
Results First Posted : January 20, 2011
Last Update Posted : February 8, 2022
Sponsor:
Information provided by (Responsible Party):
Organon and Co

Study Description
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Brief Summary:
A study to provide evidence supporting the benefit of Rizatriptan in patients who have an inadequate response to sumatriptan.

Condition or disease Intervention/treatment Phase
Acute Migraine Drug: rizatriptan Drug: Comparator: Placebo Drug: Comparator: Sumatriptan Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 109 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 for the Treatment of Acute Migraine in Sumatriptan Non-Responders
Actual Study Start Date : June 10, 2009
Actual Primary Completion Date : January 12, 2010
Actual Study Completion Date : January 12, 2010

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine
MedlinePlus related topics: Migraine

Arms and Interventions
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Arm Intervention/treatment
Experimental: Treatment Sequence A
Rizatriptan - Rizatriptan - Placebo
 Drug: rizatriptan
Single dose of 10 mg orally disintegrating tablet at onset of migraine attack

Drug: Comparator: Placebo
Placebo to Rizatriptan
Experimental: Treatment Sequence B
Rizatriptan - Placebo - Rizatriptan
 Drug: rizatriptan
Single dose of 10 mg orally disintegrating tablet at onset of migraine attack

Drug: Comparator: Placebo
Placebo to Rizatriptan
Experimental: Treatment Sequence C
Placebo - Rizatriptan - Rizatriptan
 Drug: rizatriptan
Single dose of 10 mg orally disintegrating tablet at onset of migraine attack

Drug: Comparator: Placebo
Placebo to Rizatriptan
Baseline Phase
Sumatriptan
 Drug: Comparator: Sumatriptan
single dose of generic sumatriptan 100 mg at onset of migraine attack


Outcome Measures
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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. 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.


Eligibility Criteria
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Information from the National Library of Medicine

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

Inclusion Criteria:

  • Patient has a history of migraine with or without aura for 1 year or more with 2-8 moderate or severe migraine attacks per month
  • Patient generally does not respond to treatment with sumatriptan
  • Patient of reproductive potential agrees to remain abstinent or use one method of highly effective birth control (i.e. IUD, condoms, hormonal contraceptive, diaphragm, vasectomy) for the duration of the study
  • Patient is able to complete paper diary

Exclusion Criteria:

  • Patient is pregnant or breast feeding or excepts to become pregnant during the study
  • Patient has history of mild migraine attacks or migraines that usually resolve spontaneously in less than 2 hours
  • Patient has basilar or hemiplegic migraines
  • Patient is unable to distinguish between migraine attacks from other types of headaches
  • Patient has more than 15 headache-days per month
  • Patient was greater than 50 years old at age of migraine onset
  • Patient has failed to respond to 3 or more triptans
  • Patient has a repeated history of failing to respond to or tolerate rizatriptan
  • Patient uses opioids as primary migraine therapy
  • Patient uses daily opioids
  • Patient has a history of Cerebrovascular Accident (CVA) or other significant cardiovascular disease
  • Patient has uncontrolled hypertension
  • Patient has a history of neoplastic disease
  • Patient is taking a serotonin reuptake inhibitor (SSRI or SNRI) where the dose has changed 3 months prior to screening
  • Patient has a history of drug or alcohol abuse
Contacts and Locations
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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): NCT00894556


Sponsors and Collaborators
Organon and Co
Investigators
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Study Director: Medical Monitor Merck Sharp & Dohme Corp.
More Information
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Publications of Results:

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Responsible Party: Organon and Co
ClinicalTrials.gov Identifier: NCT00894556    
Other Study ID Numbers: 0462-087
2009_587
First Posted: May 7, 2009    Key Record Dates
Results First Posted: January 20, 2011
Last Update Posted: February 8, 2022
Last Verified: February 2022
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
Keywords provided by Organon and Co:
Treatment of acute migraine with or without aura in adults
Additional relevant MeSH terms:
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Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Sumatriptan
Rizatriptan
 Vasoconstrictor Agents
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs