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

Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Migraine, Acute

Intervention: rizatriptan (Drug); placebo (Drug); rizatriptan (Drug); placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Merck Sharp & Dohme Corp.

Summary

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

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: Pain Freedom at 2 Hours Post Dose in Participants Between 12 and 17 Years of Age

Secondary outcome:

Pain Relief at 2 Hours Post Dose in Participants Between 12 and 17 Years of Age

Pain Freedom at 2 Hours Post Dose in Participants Between 6 and 17 Years of Age

Pain Relief at 2 Hours Post Dose in Participants Between 6 and 17 Years of Age

Eligibility

Minimum age: 6 Years. Maximum age: 17 Years. Gender(s): Both.

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, 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.

Locations and Contacts

Additional Information

Starting date: November 2009
Last updated: February 20, 2015

Page last updated: August 23, 2015

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