240 migraine patients of both sex and aged 6-17 years old (>20 kg in weight), with at least a 6-month history of migraine attacks (>1 and <8 moderate to severe attacks per month in 2 months before screening visit), with or without aura as defined by International Headache Society criteria, usually lasting >3 hours (when untreated). 

They had an unsatisfactory response to nonsteroidal anti-inflammatory drugs or acetaminophen/paracetamol

Randomized, double-blind, placebo-controlled, parallel-group outpatient study

Patients had a run-in with weight-based rizatriptan dosing: 5 mg for <40 kg, 10 mg for >40 kg. In the Stage 1 run-in, patients were randomized in a ratio of 20:1 placebo:rizatriptan and were instructed to treat within 30 minutes of a moderate/severe migraine. 

Patients with mild/no pain after 15 minutes of treatment (responders) took no further study medication, whereas patients with moderate/severe pain (non-responders) proceeded to take study medication in Stage 2. 

Nonresponders who received placebo in Stage 1 were randomized 1:1 to rizatriptan:placebo, whereas non-responders who received rizatriptan in Stage 1 were allocated to placebo in Stage 2. 

Pain freedom at 2 hours after Stage 2 dose (Pain freedom was definedas a reduction in pain from moderate or severe to no pain)

Rizatriptan was superior for greater response rates in pain freedom at 2 hours in 12 -17 year-olds compared with placebo (30.6% vs. 22.0%, odds ratio=1.55) (Figure 1)

In 6-17-year-olds, rizatriptan was better for 2-hour pain freedom as compared to placebo (33.0% vs 24.2%) (Figure 1)

Rizatriptan treatment showed higher response rate for 2-hour pain freedom as compared to placebo in a subgroup analysis of patients weighing <40 kg (39.4% vs. 36.7%) as well as those weighing >40 kg (30.7% vs. 20.5%)

In the post hoc analysis for 2-hour pain relief, rizatriptan was better than placebo in 12-17-year-olds (51.8% vs. 42.7%, respectively; p-value=0.033) and 6-17-year-olds (52.4% vs. 43.3%, respectively; p-value=0.019)

Higher percentage of patients felt ‘a lot better’ for rizatriptan versus placebo across all age groups (33.8% vs. 26.9% in 12–17-year-olds, 44.9% vs. 29.7% in 6–11-year-olds, and 36.7% vs. 27.6% in 6–17-year-olds)

Rizatriptan was well tolerated in acute treatment of pediatric migraineurs with adverse events similar to placebo across the different age groups.