Back to resultsA Study to Evaluate the Efficacy and Tolerability of Rizatriptan for Treatment of Acute Migraine (0462-087)
Primary Purpose
Acute Migraine
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
rizatriptan
Comparator: Placebo
Comparator: Sumatriptan
Sponsored by
About this trial
This is an interventional treatment trial for Acute Migraine focused on measuring Treatment of acute migraine with or without aura in adults
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Other
Arm Label
Treatment Sequence A
Treatment Sequence B
Treatment Sequence C
Baseline Phase
Arm Description
Rizatriptan - Rizatriptan - Placebo
Rizatriptan - Placebo - Rizatriptan
Placebo - Rizatriptan - Rizatriptan
Sumatriptan
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00894556
Brief Title
A Study to Evaluate the Efficacy and Tolerability of Rizatriptan for Treatment of Acute Migraine (0462-087)
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
June 10, 2009 (Actual)
Primary Completion Date
January 12, 2010 (Actual)
Study Completion Date
January 12, 2010 (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
A study to provide evidence supporting the benefit of Rizatriptan in patients who have an inadequate response to sumatriptan.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Migraine
Keywords
Treatment of acute migraine with or without aura in adults
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
109 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment Sequence A
Arm Type
Experimental
Arm Description
Rizatriptan - Rizatriptan - Placebo
Arm Title
Treatment Sequence B
Arm Type
Experimental
Arm Description
Rizatriptan - Placebo - Rizatriptan
Arm Title
Treatment Sequence C
Arm Type
Experimental
Arm Description
Placebo - Rizatriptan - Rizatriptan
Arm Title
Baseline Phase
Arm Type
Other
Arm Description
Sumatriptan
Intervention Type
Drug
Intervention Name(s)
rizatriptan
Intervention Description
Single dose of 10 mg orally disintegrating tablet at onset of migraine attack
Intervention Type
Drug
Intervention Name(s)
Comparator: Placebo
Intervention Description
Placebo to Rizatriptan
Intervention Type
Drug
Intervention Name(s)
Comparator: Sumatriptan
Intervention Description
single dose of generic sumatriptan 100 mg at onset of 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
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
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 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
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
21078681
Citation
Seeburger JL, Taylor FR, Friedman D, Newman L, Ge Y, Zhang Y, Hustad CM, Lasorda J, Fan X, Hewitt D, Ho T, Connor KM. Efficacy and tolerability of rizatriptan for the treatment of acute migraine in sumatriptan non-responders. Cephalalgia. 2011 May;31(7):786-96. doi: 10.1177/0333102410390399. Epub 2010 Nov 15.
Results Reference
result
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A Study to Evaluate the Efficacy and Tolerability of Rizatriptan for Treatment of Acute Migraine (0462-087)
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