Efficacy and tolerability of rizatriptan in pediatric migraineurs: Results from a randomized, double-blind, placebo-controlled trial using a novel adaptive enrichment design
Ho TW et al. – Rizatriptan demonstrated a statistically significant improvement over placebo in eliminating pain and was generally well tolerated in migraineurs aged 12–17 and 6–17 years.Methods
- Randomized, double–blind, placebo–controlled, parallel–group trial in migraineurs 6–17 years old with unsatisfactory response to nonsteroidal anti–inflammatory drugs or acetaminophen/paracetamol.
- The trial included a double–blind run–in with weight–based rizatriptan dosing (5mg for <40kg, 10mg for ≥40kg).
- 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.
- Non–responders 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.
- The primary efficacy endpoint was pain freedom at 2 hours after Stage 2 dose in 12–17–year–olds.
- A higher proportion of 12–17–year–olds on rizatriptan had pain freedom at 2 hours compared with those on placebo: 87/284 (30.6%) versus 63/286 (22.0%), odds ratio=1.55 [95% CI: 1.06 to 2.26], p=0.025.
- Adverse events within 14 days of dose in 12–17–year–olds were similar for rizatriptan and placebo.
- The pattern of findings was similar in 6–17–year–olds.