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

Phase 3

Completed

Conditions: Migraine, Acute

Interventions: Drug: rizatriptan
Drug: placebo

Registration Number: NCT01001234

Lead Sponsor: Organon and Co

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

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 1382

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Stage 1: rizatriptan	rizatriptan	-
Stage 1: placebo	placebo	-
Stage 2: rizatriptan	rizatriptan	-
Stage 2: placebo	placebo	-

Primary Outcome Measures

Name	Time	Method
Pain Freedom at 2 Hours Post Dose in Participants Between 12 and 17 Years of Age	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 Outcome Measures

Name	Time	Method
Pain Relief at 2 Hours Post Dose in Participants Between 6 and 17 Years of Age	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 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.
Pain Relief at 2 Hours Post Dose in Participants Between 12 and 17 Years of Age	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 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.
Pain Freedom at 2 Hours Post Dose in Participants Between 6 and 17 Years of Age	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.