Back to resultsA Study to Evaluate the Safety and Tolerability of Rizatriptan for Long Term Treatment of Acute Migraine in Children and Adolescents (MK-0462-086 AM3)
Primary Purpose
Acute Migraine With or Without Aura in Adolescents
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
rizatriptan benzoate
Sponsored by
About this trial
This is an interventional treatment trial for Acute Migraine With or Without Aura in Adolescents focused on measuring acute migraine with or without aura in adolescents
Eligibility Criteria
Inclusion Criteria:
- Patient is between 12 and 17 years of age inclusive at screening Visit 1
- Patient weighs at least 20 kg (44 pounds)
- Patient has had a history of unilateral or bilateral migraine headache with or without aura >6 months with ≥1 to ≤8 mild, moderate or severe migraine attacks per month in the 2 months prior to screening Visit 1
- Patient has a history of migraine defined by International Headache Society (IHS) migraine definitions
- The parent or guardian and patient agree to the patient's participation in the study as indicated by parental/guardian signature on the consent form and patient assent
- For patients taking migraine prophylactic medication, treatment regimen is stable and has been taken for at least 3 months prior to Visit 1
Exclusion Criteria:
- Patient is pregnant or breast-feeding, or is a female expecting to conceive within the projected duration of study participation
- Patient has a history of mild migraine attacks or migraines that resolve in less than 2 hours
- Patient has basilar or hemiplegic migraine headaches
- Patient has >15 headache-days per month OR has taken medication for acute headache on more than 10 days per month in any of the 3 months prior to screening
- Patient has uncontrolled high blood pressure, uncontrolled diabetes, human immunodeficiency virus (HIV), any cancer, or any other significant disease
- Patient has a history cardiovascular problems or stroke
- Patient has either demonstrated hypersensitivity to or experienced a serious adverse event in response to rizatriptan
- Patient has demonstrated hypersensitivity to or experienced a serious adverse event in response to 3 or more classes of drugs (over-the-counter and prescription)
- Patient did not experience satisfactory relief from migraine pain to prior treatment with 2 or more adequate courses of 5-hydroxytryptamine 1 (5HT1) agonists
- Patient has a recent history (within the past year) or current evidence of drug or alcohol abuse or is a "recreational user" of illicit drugs
- Patient is currently taking monoamine oxidase inhibitors, methysergide, or propranolol, and is unable to tolerate withdrawal of these medications for the intervals required
- Patient is currently participating or has participated in a study with an investigational compound or device within 30 days of screening
- Patient is legally or mentally incapacitated
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Rizatriptan
Arm Description
Rizatriptan benzoate
Outcomes
Primary Outcome Measures
Number of Participants With Adverse Events (AEs) Within 24 Hours Post Any Dose
An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration. Participants reported AEs in a diary and these were collected by the study site at visits at 1, 2, 3, 4, 6, 9, and 12 months after Screening visit. Participants with an AE occurring within 24 hours after any dose administered during the study are counted once in this summary.
Number of Participants With AEs Within 14 Days Post Any Dose
An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration. Participants reported AEs in a diary and these were collected by the study site at visits at 1, 2, 3, 4, 6, 9, and 12 months after Screening visit. AEs were assessed in a phone contact 14 days after the last dose of study medication. Participants with an AE occurring within 14 days after any dose administered during the study are counted once in this summary.
Number of Participants Discontinued From Study Due to AEs Occurring Within 24 Hours Post Dose
An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration. Participants who discontinued due to an AE occurring within 24 hours post dose are counted in this summary.
Number of Participants Discontinued From Study Due to AEs Occurring Within 14 Days Post Dose
An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration. Participants who discontinued due to an AE occurring within 14 days post dose are counted in this summary.
Secondary Outcome Measures
Percentage of Participant's Migraine Attacks With Pain Freedom at 2 Hours Post Dose
Pain intensity was assessed using a 5-Face Pain Scale ranging from 1=no pain to 5=very bad pain. Pain freedom (PF) was defined as a reduction in severity from a rating of 5, 4, 3 or 2 (mild, moderate or severe pain) before the dose to a rating of 1 (no pain) at 2 hours after dosing. Pain intensity ratings were reported in diaries returned at visits at 1, 2, 3, 4, 6, 9, and 12 months after Screening visit. PF at 2 hours was summarized as follows: the percentage of treated attacks with PF at 2 hours was calculated for each patient first, then the mean across all patients was calculated.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01004263
Brief Title
A Study to Evaluate the Safety and Tolerability of Rizatriptan for Long Term Treatment of Acute Migraine in Children and Adolescents (MK-0462-086 AM3)
Official Title
A Worldwide, Open Label, Clinical Trial to Examine the Long Term Safety and Tolerability of Rizatriptan in Pediatric Migraineurs for the Treatment of Migraine With or Without Aura
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
December 1, 2009 (Actual)
Primary Completion Date
April 18, 2011 (Actual)
Study Completion Date
April 18, 2011 (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
To provide long term safety data for rizatriptan in children and adolescents. The primary hypothesis of the study is that rizatriptan is well tolerated in the long term treatment of acute migraine in pediatric patients age 12-17 years.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Migraine With or Without Aura in Adolescents
Keywords
acute migraine with or without aura in adolescents
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
674 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Rizatriptan
Arm Type
Experimental
Arm Description
Rizatriptan benzoate
Intervention Type
Drug
Intervention Name(s)
rizatriptan benzoate
Other Intervention Name(s)
MK-0462, Maxalt
Intervention Description
Single dose of 5 mg or 10 mg orally disintegrating tablet at onset of migraine attack
Primary Outcome Measure Information:
Title
Number of Participants With Adverse Events (AEs) Within 24 Hours Post Any Dose
Description
An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration. Participants reported AEs in a diary and these were collected by the study site at visits at 1, 2, 3, 4, 6, 9, and 12 months after Screening visit. Participants with an AE occurring within 24 hours after any dose administered during the study are counted once in this summary.
Time Frame
Up to 24 hours post dose
Title
Number of Participants With AEs Within 14 Days Post Any Dose
Description
An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration. Participants reported AEs in a diary and these were collected by the study site at visits at 1, 2, 3, 4, 6, 9, and 12 months after Screening visit. AEs were assessed in a phone contact 14 days after the last dose of study medication. Participants with an AE occurring within 14 days after any dose administered during the study are counted once in this summary.
Time Frame
Up to 14 days post dose
Title
Number of Participants Discontinued From Study Due to AEs Occurring Within 24 Hours Post Dose
Description
An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration. Participants who discontinued due to an AE occurring within 24 hours post dose are counted in this summary.
Time Frame
Up to 24 hours post dose
Title
Number of Participants Discontinued From Study Due to AEs Occurring Within 14 Days Post Dose
Description
An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration. Participants who discontinued due to an AE occurring within 14 days post dose are counted in this summary.
Time Frame
Up to 14 days post dose
Secondary Outcome Measure Information:
Title
Percentage of Participant's Migraine Attacks With Pain Freedom at 2 Hours Post Dose
Description
Pain intensity was assessed using a 5-Face Pain Scale ranging from 1=no pain to 5=very bad pain. Pain freedom (PF) was defined as a reduction in severity from a rating of 5, 4, 3 or 2 (mild, moderate or severe pain) before the dose to a rating of 1 (no pain) at 2 hours after dosing. Pain intensity ratings were reported in diaries returned at visits at 1, 2, 3, 4, 6, 9, and 12 months after Screening visit. PF at 2 hours was summarized as follows: the percentage of treated attacks with PF at 2 hours was calculated for each patient first, then the mean across all patients was calculated.
Time Frame
2 hours post dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient is between 12 and 17 years of age inclusive at screening Visit 1
Patient weighs at least 20 kg (44 pounds)
Patient has had a history of unilateral or bilateral migraine headache with or without aura >6 months with ≥1 to ≤8 mild, moderate or severe migraine attacks per month in the 2 months prior to screening Visit 1
Patient has a history of migraine defined by International Headache Society (IHS) migraine definitions
The parent or guardian and patient agree to the patient's participation in the study as indicated by parental/guardian signature on the consent form and patient assent
For patients taking migraine prophylactic medication, treatment regimen is stable and has been taken for at least 3 months prior to Visit 1
Exclusion Criteria:
Patient is pregnant or breast-feeding, or is a female expecting to conceive within the projected duration of study participation
Patient has a history of mild migraine attacks or migraines that resolve in less than 2 hours
Patient has basilar or hemiplegic migraine headaches
Patient has >15 headache-days per month OR has taken medication for acute headache on more than 10 days per month in any of the 3 months prior to screening
Patient has uncontrolled high blood pressure, uncontrolled diabetes, human immunodeficiency virus (HIV), any cancer, or any other significant disease
Patient has a history cardiovascular problems or stroke
Patient has either demonstrated hypersensitivity to or experienced a serious adverse event in response to rizatriptan
Patient has demonstrated hypersensitivity to or experienced a serious adverse event in response to 3 or more classes of drugs (over-the-counter and prescription)
Patient did not experience satisfactory relief from migraine pain to prior treatment with 2 or more adequate courses of 5-hydroxytryptamine 1 (5HT1) agonists
Patient has a recent history (within the past year) or current evidence of drug or alcohol abuse or is a "recreational user" of illicit drugs
Patient is currently taking monoamine oxidase inhibitors, methysergide, or propranolol, and is unable to tolerate withdrawal of these medications for the intervals required
Patient is currently participating or has participated in a study with an investigational compound or device within 30 days of screening
Patient is legally or mentally incapacitated
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
23078588
Citation
Hewitt DJ, Pearlman E, Hamalainen M, Lewis D, Connor KM, Michelson D, Ceesay P, Assaid C, Bachman R, Harper Mozley L, Dupre N, Strickler N, Mahoney E, Lines C, Ho TW. Long-term open-label safety study of rizatriptan acute treatment in pediatric migraineurs. Headache. 2013 Jan;53(1):104-117. doi: 10.1111/j.1526-4610.2012.02285.x. Epub 2012 Oct 18.
Results Reference
derived
Learn more about this trial
A Study to Evaluate the Safety and Tolerability of Rizatriptan for Long Term Treatment of Acute Migraine in Children and Adolescents (MK-0462-086 AM3)
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