We found a match
Your institution may have rights to this item. Sign in to continue.
- Title
Efficacy and tolerability of rizatriptan in pediatric migraineurs: Results from a randomized, double-blind, placebo-controlled trial using a novel adaptive enrichment design.
- Authors
Ho, Tony W; Pearlman, Eric; Lewis, Donald; Hämäläinen, Mirja; Connor, Kathryn; Michelson, David; Zhang, Ying; Assaid, Christopher; Mozley, Lyn Harper; Strickler, Nancy; Bachman, Robert; Mahoney, Erin; Lines, Christopher; Hewitt, David J
- Abstract
Background: Treatment options for children and adolescents with migraine are limited. This study evaluated rizatriptan for the acute treatment of migraine in children and adolescents.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 (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. 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.Results: 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.Conclusion: 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.Trial Registration: ClinicalTrials.gov NCT01001234
- Subjects
HEADACHE treatment; MIGRAINE; MIGRAINE in children; PAIN in children; ANTI-inflammatory agents; ACETAMINOPHEN; THERAPEUTICS
- Publication
Cephalalgia, 2012, Vol 32, Issue 10, p750
- ISSN
0333-1024
- Publication type
Article
- DOI
10.1177/0333102412451358