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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)

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: Acute Migraine With or Without Aura in Adolescents

Intervention: rizatriptan benzoate (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Merck Sharp & Dohme Corp.

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck Sharp & Dohme Corp.

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.

Clinical Details

Official title: 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

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Number of Participants With Adverse Events (AEs) Within 24 Hours Post Any Dose

Number of Participants With AEs Within 14 Days Post Any Dose

Number of Participants Discontinued From Study Due to AEs Occurring Within 24 Hours Post Dose

Number of Participants Discontinued From Study Due to AEs Occurring Within 14 Days Post Dose

Secondary outcome: Percentage of Participant's Migraine Attacks With Pain Freedom at 2 Hours Post Dose

Eligibility

Minimum age: 12 Years. Maximum age: 17 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

Additional Information

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

Page last updated: August 23, 2015

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