A Study to Evaluate the Efficacy and Tolerability of Rizatriptan for Treatment of Acute Migraine in Children and Adolescents (MK-0462-082 AM7)

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

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

Study Overview

• Status: Completed
• Conditions: Migraine, Acute
• Intervention / Treatment: Drug: rizatriptan; Drug: rizatriptan; Drug: placebo; Drug: placebo

• Study Type: Interventional
• Enrollment (Actual): 1382
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 13 years (Child)
• Accepts Healthy Volunteers: No

Description

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, human immunodeficiency virus (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 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, selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs) 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Stage 1: rizatriptan	Drug: rizatriptan; For participants randomized to rizatriptan in Stage 1: a single 5 or 10 mg rizatriptan orally disintegrating tablet (ODT) was to be taken within 30 minutes of onset of qualifying migraine (defined as a migraine of moderate or severe intensity). Rizatriptan dose administered was based on participant weight at Screening: those <40 kg received 5 mg tablet, those ≥40 kg received 10 mg tablet.; Other Names: Maxalt; MK-0462; Drug: rizatriptan; For participants randomized to rizatriptan in Stage 2 (must have taken placebo in Stage 1 and was Non-Responder [moderate or severe pain 15 minutes after dose] to be randomized at Stage 2): a single 5 or 10 mg rizatriptan ODT was to be taken approximately 15 minutes post Stage 1 dose, to treat same qualifying migraine treated in Stage 1. Rizatriptan dose administered was based on participant weight at Screening: those <40 kg received 5 mg tablet, those ≥40 kg received 10 mg tablet.; Other Names: Maxalt; MK-0462
Placebo Comparator: Stage 1: placebo	Drug: placebo; For participants randomized to placebo in Stage 1: a single placebo ODT was to be taken within 30 minutes of onset of qualifying migraine.; Drug: placebo; For participants randomized to placebo in Stage 2 (must have taken placebo in Stage 1 and was Non-Responder to be randomized at Stage 2) or allocated to placebo in Stage 2 (took rizatriptan in Stage 1 and was Non-Responder): a single placebo ODT was to be taken approximately 15 minutes post Stage 1 dose, to treat same qualifying migraine treated in Stage 1.
Experimental: Stage 2: rizatriptan	Drug: rizatriptan; For participants randomized to rizatriptan in Stage 1: a single 5 or 10 mg rizatriptan orally disintegrating tablet (ODT) was to be taken within 30 minutes of onset of qualifying migraine (defined as a migraine of moderate or severe intensity). Rizatriptan dose administered was based on participant weight at Screening: those <40 kg received 5 mg tablet, those ≥40 kg received 10 mg tablet.; Other Names: Maxalt; MK-0462; Drug: rizatriptan; For participants randomized to rizatriptan in Stage 2 (must have taken placebo in Stage 1 and was Non-Responder [moderate or severe pain 15 minutes after dose] to be randomized at Stage 2): a single 5 or 10 mg rizatriptan ODT was to be taken approximately 15 minutes post Stage 1 dose, to treat same qualifying migraine treated in Stage 1. Rizatriptan dose administered was based on participant weight at Screening: those <40 kg received 5 mg tablet, those ≥40 kg received 10 mg tablet.; Other Names: Maxalt; MK-0462
Placebo Comparator: Stage 2: placebo	Drug: placebo; For participants randomized to placebo in Stage 1: a single placebo ODT was to be taken within 30 minutes of onset of qualifying migraine.; Drug: placebo; For participants randomized to placebo in Stage 2 (must have taken placebo in Stage 1 and was Non-Responder to be randomized at Stage 2) or allocated to placebo in Stage 2 (took rizatriptan in Stage 1 and was Non-Responder): a single placebo ODT was to be taken approximately 15 minutes post Stage 1 dose, to treat same qualifying migraine treated in Stage 1.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Freedom at 2 Hours Post Dose in Participants Between 12 and 17 Years of Age	Pain intensity was assessed using a 5-Face Pain Scale ranging from 1=no pain to 5=very bad pain. Pain freedom was defined as a reduction in severity from a rating of 3, 4 or 5 (moderate or severe pain) at the Stage 2 baseline (15 minutes post Stage 1 dose) to a rating of 1 (no pain) at 2 hours post Stage 2 dose. Missing data were imputed by carrying forward the preceding Stage 2 pain intensity values. Missing Stage 2 baseline values were imputed by carrying forward the Stage 1 baseline value, if available.	2 hours post Stage 2 dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Relief at 2 Hours Post Dose in Participants Between 12 and 17 Years of Age	Pain intensity was assessed using a 5-Face Pain Scale ranging from 1=no pain to 5=very bad pain. Pain relief was defined as a reduction in severity from a rating of 3, 4 or 5 (moderate or severe pain) at the Stage 2 baseline (15 minutes post Stage 1 dose) to a rating of 2 or 1 (mild or no pain) at 2 hours post Stage 2 dose. Missing data were imputed by carrying forward the preceding Stage 2 pain intensity values. Missing Stage 2 baseline values were imputed by carrying forward the Stage 1 baseline value, if available.	2 hours post Stage 2 dose
Pain Freedom at 2 Hours Post Dose in Participants Between 6 and 17 Years of Age	Pain intensity was assessed using a 5-Face Pain Scale ranging from 1=no pain to 5=very bad pain. Pain freedom was defined as a reduction in severity from a rating of 3, 4 or 5 (moderate or severe pain) at the Stage 2 baseline (15 minutes post Stage 1 dose) to a rating of 1 (no pain) at 2 hours post Stage 2 dose. Missing data were imputed by carrying forward the preceding Stage 2 pain intensity values. Missing Stage 2 baseline values were imputed by carrying forward the Stage 1 baseline value, if available.	2 hours post Stage 2 dose
Pain Relief at 2 Hours Post Dose in Participants Between 6 and 17 Years of Age	Pain intensity was assessed using a 5-Face Pain Scale ranging from 1=no pain to 5=very bad pain. Pain relief was defined as a reduction in severity from a rating of 3, 4 or 5 (moderate or severe pain) at the Stage 2 baseline (15 minutes post Stage 1 dose) to a rating of 2 or 1 (mild or no pain) at 2 hours post Stage 2 dose. Missing data were imputed by carrying forward the preceding Stage 2 pain intensity values. Missing Stage 2 baseline values were imputed by carrying forward the Stage 1 baseline value, if available.	2 hours post Stage 2 dose

Collaborators and Investigators

• Sponsor: Organon and Co

Publications and helpful links

General Publications

• Ho TW, Pearlman E, Lewis D, Hamalainen M, Connor K, Michelson D, Zhang Y, Assaid C, Mozley LH, Strickler N, Bachman R, Mahoney E, Lines C, Hewitt DJ; Rizatriptan Protocol 082 Pediatric Migraine Study Group. Efficacy and tolerability of rizatriptan in pediatric migraineurs: results from a randomized, double-blind, placebo-controlled trial using a novel adaptive enrichment design. Cephalalgia. 2012 Jul;32(10):750-65. doi: 10.1177/0333102412451358. Epub 2012 Jun 18.

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2009
• Primary Completion (Actual): April 21, 2011
• Study Completion (Actual): April 21, 2011

Study Registration Dates

• First Submitted: October 23, 2009
• First Submitted That Met QC Criteria: October 23, 2009
• First Posted (Estimated): October 26, 2009

Study Record Updates

• Last Update Posted (Actual): May 7, 2024
• Last Update Submitted That Met QC Criteria: April 17, 2024
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Serotonin Agents; Serotonin Receptor Agonists; Rizatriptan
• Other Study ID Numbers: 0462-082; 2009_679 (Other Identifier: Merck Registration Number); CTRI/2010/091/000407 (Other Identifier: CTRI)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD 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