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

Organon and Co0 sites1,382 target enrollmentNovember 30, 2009

ConditionsMigraine, Acute

Interventionsrizatriptan placebo

Drugsrizatriptan placebo

Overview

Phase: Phase 3
Intervention: rizatriptan
Conditions: Migraine, Acute
Sponsor: Organon and Co
Enrollment: 1382
Primary Endpoint: Pain Freedom at 2 Hours Post Dose in Participants Between 12 and 17 Years of Age
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

November 30, 2009

End Date

April 21, 2011

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Organon and Co

Responsible Party

Sponsor

Eligibility 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

Arms & Interventions

Stage 1: rizatriptan

Intervention: rizatriptan

Stage 1: placebo

Intervention: placebo

Stage 2: rizatriptan

Intervention: rizatriptan

Stage 2: placebo

Intervention: placebo

Outcomes

Primary Outcomes

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

Time Frame: 2 hours post Stage 2 dose

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.

Secondary Outcomes

Pain Relief at 2 Hours Post Dose in Participants Between 6 and 17 Years of Age(2 hours post Stage 2 dose)
Pain Relief at 2 Hours Post Dose in Participants Between 12 and 17 Years of Age(2 hours post Stage 2 dose)
Pain Freedom at 2 Hours Post Dose in Participants Between 6 and 17 Years of Age(2 hours post Stage 2 dose)