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A Study to Evaluate the Efficacy and Tolerability of Rizatriptan for Treatment of AcuteMigraine in Children and Adolescents (MK0462-082 AM7)
This study has been completed.

First Received on October 23, 2009.   Last Updated on May 18, 2011   History of Changes
Sponsor: Merck
Information provided by: Merck
ClinicalTrials.gov Identifier: NCT01001234
  Purpose

This Clinical Trial evaluates the Safety and Efficacy of Rizatriptan for the Acute Treatment of Migraine in Children and Adolescents.


Condition Intervention Phase
Migraine, Acute
Drug: rizatriptan
Drug: Placebo
Phase III

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Worldwide, Randomized, Double Blind, Placebo-Controlled, Parallel Group Clinical Trial to Evaluate the Safety and Efficacy of Rizatriptan for the Acute Treatment of Migraine in Children and Adolescents

Resource links provided by NLM:


Further study details as provided by Merck:

Primary Outcome Measures:
  • Proportion of patients between 12 and 17 years of age who have pain freedom [ Time Frame: 2 hours post dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of patients between 12 and 17 years of age who have pain relief [ Time Frame: 2 hours post dose ] [ Designated as safety issue: No ]
  • Proportion of patients between 6 and 17 years of age who have pain freedom [ Time Frame: 2 hours post dose ] [ Designated as safety issue: No ]
  • Proportion of patients between 6 and 17 years of age who have pain relief [ Time Frame: 2 hours post dose ] [ Designated as safety issue: No ]

Estimated Enrollment: 1240
Study Start Date: December 2009
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Stage 1: 5mg rizatriptan Drug: rizatriptan
5 or 10mg rizatriptan orally disintegrating tablet (ODT) administered within 30 minutes following the onset of a qualifying migraine (Stage 1) or administered immediately after interactive voice response system (IVRS) just after the 15-minute post dose response for Stage 1 confirmation (Stage 2)
Other Name: MK-0462
Experimental: Stage 1: 10mg rizatriptan Drug: rizatriptan
5 or 10mg rizatriptan orally disintegrating tablet (ODT) administered within 30 minutes following the onset of a qualifying migraine (Stage 1) or administered immediately after interactive voice response system (IVRS) just after the 15-minute post dose response for Stage 1 confirmation (Stage 2)
Other Name: MK-0462
Placebo Comparator: Stage 1: placebo Drug: Placebo
Matching placebo ODT tablet administered within 30 minutes following the onset of a qualifying migraine (Stage 1) or administered immediately after IVRS just after the 15-minute post dose response for Stage 1 confirmation (Stage 2)
Experimental: Stage 2: 5mg rizatriptan Drug: rizatriptan
5 or 10mg rizatriptan orally disintegrating tablet (ODT) administered within 30 minutes following the onset of a qualifying migraine (Stage 1) or administered immediately after interactive voice response system (IVRS) just after the 15-minute post dose response for Stage 1 confirmation (Stage 2)
Other Name: MK-0462
Experimental: Stage 2: 10mg rizatriptan Drug: rizatriptan
5 or 10mg rizatriptan orally disintegrating tablet (ODT) administered within 30 minutes following the onset of a qualifying migraine (Stage 1) or administered immediately after interactive voice response system (IVRS) just after the 15-minute post dose response for Stage 1 confirmation (Stage 2)
Other Name: MK-0462
Placebo Comparator: Stage 2: placebo Drug: Placebo
Matching placebo ODT tablet administered within 30 minutes following the onset of a qualifying migraine (Stage 1) or administered immediately after IVRS just after the 15-minute post dose response for Stage 1 confirmation (Stage 2)

  Eligibility

Ages Eligible for Study:   6 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient weighs at least 20 kg (44 pounds)
  • Patient has had a history of migraine with or without aura > 6 months with >= 1 to <= 8 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
  • Patient is willing to stay awake for at least 2 hours after administration of the first dose of study medication
  • Patient has not experienced satisfactory relief from migraine pain with nonsteroidal anti-inflammatory drugs (NSAIDs) or N-acetyl-p-aminophenol (APAP) treatment
  • 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, HIV, any cancer, or any other significant disease
  • Patient has a history or clinical evidence of cardiovascular problems or stroke
  • Patient has either demonstrated hypersensitivity to or experienced a serious adverse event in response to rizatriptan
  • Patient did not experience satisfactory relief from migraine pain to prior treatment with 2 or more adequate courses of 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.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Additional Information:
No publications provided

Responsible Party: Vice President, Late State Development Group Leader, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT01001234     History of Changes
Other Study ID Numbers: 2009_679, MK-0462-082
Study First Received: October 23, 2009
Last Updated: May 18, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Rizatriptan
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 09, 2012