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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)

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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.

Tracking Information
First Submitted Date  ICMJE October 28, 2009
First Posted Date  ICMJE October 29, 2009
Results First Submitted Date  ICMJE April 6, 2012
Results First Posted Date  ICMJE May 4, 2012
Last Update Posted Date June 19, 2017
Actual Study Start Date  ICMJE December 1, 2009
Actual Primary Completion Date April 18, 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 6, 2012)
  • Number of Participants With Adverse Events (AEs) Within 24 Hours Post Any Dose [ Time Frame: Up to 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 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 [ Time Frame: Up to 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 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 [ Time Frame: Up to 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 [ Time Frame: Up to 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.
Original Primary Outcome Measures  ICMJE
 (submitted: October 28, 2009)
Percentage of patients with adverse events [ Time Frame: Up to 1 year exposure ]
Change History Complete list of historical versions of study NCT01004263 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 29, 2012)
Percentage of Participant's Migraine Attacks With Pain Freedom at 2 Hours Post Dose [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 28, 2009)
Efficacy of rizatriptan, measured by proportion of patients experiencing pain freedom, defined as a reduction of a mild, moderate or severe headache to no pain, at 2 hours [ Time Frame: 2 hours post dose ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Acute Migraine With or Without Aura in Adolescents
Intervention  ICMJE Drug: rizatriptan benzoate
Single dose of 5 mg or 10 mg orally disintegrating tablet at onset of migraine attack
Other Names:
  • MK-0462
  • Maxalt
Study Arms  ICMJE Experimental: Rizatriptan
Rizatriptan benzoate
Intervention: Drug: rizatriptan benzoate
Publications * Hewitt DJ, Pearlman E, Hämäläinen 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 16, 2010)
674
Original Estimated Enrollment  ICMJE
 (submitted: October 28, 2009)
630
Actual Study Completion Date  ICMJE April 18, 2011
Actual Primary Completion Date April 18, 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT01004263
Other Study ID Numbers  ICMJE 0462-086
2009_680
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
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

Responsible Party Merck Sharp & Dohme Corp.
Study Sponsor  ICMJE Merck Sharp & Dohme Corp.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
PRS Account Merck Sharp & Dohme Corp.
Verification Date May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP