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

Organon

Status and phase: Completed; Phase 3

Conditions: Migraine, Acute

Treatments: Drug: rizatriptan; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01001234

2009_679 (Other Identifier)

0462-082

CTRI/2010/091/000407 (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 1,382 patients

Sex: All

Ages: 6 to 17 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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1,382 participants in 4 patient groups, including a placebo group

Stage 1: rizatriptan

Experimental group

Treatment:

Drug: rizatriptan

Drug: rizatriptan

Stage 1: placebo

Placebo Comparator group

Treatment:

Drug: placebo

Drug: placebo

Stage 2: rizatriptan

Experimental group

Treatment:

Drug: rizatriptan

Drug: rizatriptan

Stage 2: placebo

Placebo Comparator group

Treatment:

Drug: placebo

Drug: placebo