A Study to Evaluate the Efficacy and Tolerability of Rizatriptan for Treatment of Acute Migraine in Children and Adolescents (MK-0462-082 AM7)
Condition: Migraine, Acute
MeSH terms: Migraine Disorders
Intervention: rizatriptan; placebo; rizatriptan; placebo
Intervention description: For participants randomized to rizatriptan in Stage 1: a single 5 or 10 mg rizatriptan orally disintegrating tablet (ODT) was to be taken within 30 minutes of onset of qualifying migraine (defined as a migraine of moderate or severe intensity).
Rizatriptan dose administered was based on participant weight at Screening: those <40 kg received 5 mg tablet, those ≥40 kg received 10 mg tablet.; For participants randomized to placebo in Stage 1: a single placebo ODT was to be taken within 30 minutes of onset of qualifying migraine.; For participants randomized to rizatriptan in Stage 2 (must have taken placebo in Stage 1 and was Non-Responder [moderate or severe pain 15 minutes after dose] to be randomized at Stage 2): a single 5 or 10 mg rizatriptan ODT was to be taken approximately 15 minutes post Stage 1 dose, to treat same qualifying migraine treated in Stage 1.
Rizatriptan dose administered was based on participant weight at Screening: those <40 kg received 5 mg tablet, those ≥40 kg received 10 mg tablet.; For participants randomized to placebo in Stage 2 (must have taken placebo in Stage 1 and was Non-Responder to be randomized at Stage 2) or allocated to placebo in Stage 2 (took rizatriptan in Stage 1 and was Non-Responder): a single placebo ODT was to be taken approximately 15 minutes post Stage 1 dose, to treat same qualifying migraine treated in Stage 1.
Intervention MeSH terms: Rizatriptan
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 1382.0
Sex: All
Minimum age: 6 Years
Maximum age: 17 Years
Healthy volunteers: No

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 <=
             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.