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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)

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: NCT01004263
Recruitment Status : Completed
First Posted : October 29, 2009
Results First Posted : May 4, 2012
Last Update Posted : June 19, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Acute Migraine With or Without Aura in Adolescents
Intervention Drug: rizatriptan benzoate
Enrollment 674
Recruitment Details  
Pre-assignment Details A total of 674 patients met inclusion/exclusion criteria and were allocated study drug. Of these, 606 were treated with study drug.
Arm/Group Title Rizatriptan
Hide Arm/Group Description Participants self-administered rizatriptan to treat up to 8 qualifying migraine headaches (mild, moderate, or severe pain intensity) per month, for up to 12 months. Rizatriptan dose, administered as a single oral tablet, was either 5 or 10 mg, based on participant weight (5 mg if <40 kg, 10 mg if ≥40 kg).
Period Title: Overall Study
Started 606 [1]
Completed 427
Not Completed 179
Reason Not Completed
Adverse Event             15
Withdrawal by Subject             58
Protocol Violation             10
Lost to Follow-up             64
Lack of Efficacy             13
Pregnancy             2
Physician Decision             15
Lack of Qualifying Event             2
[1]
Participants who took study drug
Arm/Group Title Rizatriptan
Hide Arm/Group Description Participants self-administered rizatriptan to treat up to 8 qualifying migraine headaches (mild, moderate, or severe pain intensity) per month, for up to 12 months. Rizatriptan dose, administered as a single oral tablet, was either 5 or 10 mg, based on participant weight (5 mg if <40 kg, 10 mg if ≥40 kg).
Overall Number of Baseline Participants 606
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 606 participants
14.7  (1.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 606 participants
Female
372
  61.4%
Male
234
  38.6%
1.Primary Outcome
Title Number of Participants With Adverse Events (AEs) Within 24 Hours Post Any Dose
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who administered at least one dose of study medication
Arm/Group Title Rizatriptan
Hide Arm/Group Description:
Participants self-administered rizatriptan to treat up to 8 qualifying migraine headaches (mild, moderate, or severe pain intensity) per month, for up to 12 months. Rizatriptan dose, administered as a single oral tablet, was either 5 or 10 mg, based on participant weight (5 mg if <40 kg, 10 mg if ≥40 kg).
Overall Number of Participants Analyzed 606
Measure Type: Number
Unit of Measure: participants
322
2.Primary Outcome
Title Number of Participants With AEs Within 14 Days Post Any Dose
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who administered at least one dose of study medication
Arm/Group Title Rizatriptan
Hide Arm/Group Description:
Participants self-administered rizatriptan to treat up to 8 qualifying migraine headaches (mild, moderate, or severe pain intensity) per month, for up to 12 months. Rizatriptan dose, administered as a single oral tablet, was either 5 or 10 mg, based on participant weight (5 mg if <40 kg, 10 mg if ≥40 kg).
Overall Number of Participants Analyzed 606
Measure Type: Number
Unit of Measure: participants
400
3.Primary Outcome
Title Number of Participants Discontinued From Study Due to AEs Occurring Within 24 Hours Post Dose
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who administered at least one dose of study medication
Arm/Group Title Rizatriptan
Hide Arm/Group Description:
Participants self-administered rizatriptan to treat up to 8 qualifying migraine headaches (mild, moderate, or severe pain intensity) per month, for up to 12 months. Rizatriptan dose, administered as a single oral tablet, was either 5 or 10 mg, based on participant weight (5 mg if <40 kg, 10 mg if ≥40 kg).
Overall Number of Participants Analyzed 606
Measure Type: Number
Unit of Measure: participants
4
4.Primary Outcome
Title Number of Participants Discontinued From Study Due to AEs Occurring Within 14 Days Post Dose
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who administered at least one dose of study medication
Arm/Group Title Rizatriptan
Hide Arm/Group Description:
Participants self-administered rizatriptan to treat up to 8 qualifying migraine headaches (mild, moderate, or severe pain intensity) per month, for up to 12 months. Rizatriptan dose, administered as a single oral tablet, was either 5 or 10 mg, based on participant weight (5 mg if <40 kg, 10 mg if ≥40 kg).
Overall Number of Participants Analyzed 606
Measure Type: Number
Unit of Measure: participants
14
5.Secondary Outcome
Title Percentage of Participant's Migraine Attacks With Pain Freedom at 2 Hours Post Dose
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who were enrolled and reported at least one treated migraine attack with at least one post treatment efficacy evaluation
Arm/Group Title Rizatriptan
Hide Arm/Group Description:
Participants self-administered rizatriptan to treat up to 8 qualifying migraine headaches (mild, moderate, or severe pain intensity) per month, for up to 12 months. Rizatriptan dose, administered as a single oral tablet, was either 5 or 10 mg, based on participant weight (5 mg if <40 kg, 10 mg if ≥40 kg).
Overall Number of Participants Analyzed 603
Mean (Standard Deviation)
Unit of Measure: percentage of participant's attacks
46.3  (31.9)
Time Frame Up to 12 months after start of study drug administration
Adverse Event Reporting Description AE tables include all enrolled participants who administered at least one dose of study medication
 
Arm/Group Title Rizatriptan
Hide Arm/Group Description Participants self-administered rizatriptan to treat up to 8 qualifying migraine headaches (mild, moderate, or severe pain intensity) per month, for up to 12 months. Rizatriptan dose, administered as a single oral tablet, was either 5 or 10 mg, based on participant weight (5 mg if <40 kg, 10 mg if ≥40 kg).
All-Cause Mortality
Rizatriptan
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Rizatriptan
Affected / at Risk (%) # Events
Total   22/606 (3.63%)    
Cardiac disorders   
Sinus bradycardia  1/606 (0.17%)  1
Gastrointestinal disorders   
Abdominal discomfort  2/606 (0.33%)  2
General disorders   
Fatigue  1/606 (0.17%)  2
Infections and infestations   
Appendicitis  2/606 (0.33%)  2
Gastroenteritis  1/606 (0.17%)  1
Viral infection  1/606 (0.17%)  1
Injury, poisoning and procedural complications   
Fibula fracture  1/606 (0.17%)  1
Road traffic accident  1/606 (0.17%)  1
Tibia fracture  1/606 (0.17%)  1
Upper limb fracture  1/606 (0.17%)  1
Nervous system disorders   
Migraine  2/606 (0.33%)  2
Syncope  1/606 (0.17%)  1
Psychiatric disorders   
Conversion disorder  1/606 (0.17%)  1
Major depression  1/606 (0.17%)  1
Suicidal ideation  2/606 (0.33%)  2
Suicide attempt  3/606 (0.50%)  3
Respiratory, thoracic and mediastinal disorders   
Dyspnea  1/606 (0.17%)  1
Vascular disorders   
Peripheral ischemia  1/606 (0.17%)  1
1
Term from vocabulary, MedDRA 13.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Rizatriptan
Affected / at Risk (%) # Events
Total   284/606 (46.86%)    
Gastrointestinal disorders   
Nausea  40/606 (6.60%)  77
General disorders   
Fatigue  33/606 (5.45%)  111
Infections and infestations   
Nasopharyngitis  47/606 (7.76%)  56
Upper respiratory tract infection  31/606 (5.12%)  33
Injury, poisoning and procedural complications   
Accidental overdose  148/606 (24.42%)  216
Nervous system disorders   
Dizziness  52/606 (8.58%)  94
Somnolence  44/606 (7.26%)  123
1
Term from vocabulary, MedDRA 13.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Investigator agrees to delay publication of study results until Food and Drug Administration (FDA) grants pediatric exclusivity on the study drug. Investigator may publish results for his/her study site after primary publication of results of entire multicenter trial. Sponsor must be able to review all proposed results communications regarding study 60 days prior to submission for publication/presentation. Information identified by the Sponsor as confidential must be deleted prior to submission.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp
Phone: 1-800-672-6372
EMail: ClinicalTrialsDisclosure@merck.com
Layout table for additonal information
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01004263     History of Changes
Other Study ID Numbers: 0462-086
2009_680
First Submitted: October 28, 2009
First Posted: October 29, 2009
Results First Submitted: April 6, 2012
Results First Posted: May 4, 2012
Last Update Posted: June 19, 2017