Phase 3 N=1,382 Randomized Triple-blind Treatment

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

Migraine, Acute

Bottom Line

View on ClinicalTrials.gov: NCT01001234 ↗

Enrolled (actual)

1,382

Serious AEs

0.2%

Results posted

May 2012

Primary outcome: Primary: Pain Freedom at 2 Hours Post Dose in Participants Between 12 and 17 Years of Age — 87; 63; 197; 223 participants — p=0.025

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: rizatriptan (Drug); placebo (Drug)
Age: Pediatric · 6+ yrs
Sex: All
Sponsor: Organon and Co
Primary completion: Apr 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Pain Freedom at 2 Hours Post Dose in Participants Between 12 and 17 Years of Age	87; 63; 197; 223	0.025 sig
SECONDARY Pain Relief at 2 Hours Post Dose in Participants Between 12 and 17 Years of Age	167; 147; 117; 139	0.080
SECONDARY Pain Freedom at 2 Hours Post Dose in Participants Between 6 and 17 Years of Age	126; 94; 256; 294	0.010 sig
SECONDARY Pain Relief at 2 Hours Post Dose in Participants Between 6 and 17 Years of Age	220; 204; 162; 184	0.178

Summary

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

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 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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01001234). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.