Efficacy and tolerability of rizatriptan in pediatric migraineurs: results from a randomized, double-blind, placebo-controlled trial using a novel adaptive enrichment design.

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.

• Authors: Tony W Ho, Eric Pearlman, Donald Lewis, Mirja Hämäläinen, Kathryn Connor, David Michelson, Ying Zhang, Christopher Assaid, Lyn Harper Mozley, Nancy Strickler, Robert Bachman, Erin Mahoney, Christopher Lines, David J Hewitt, Rizatriptan Protocol 082 Pediatric Migraine Study Group
• Journal: Cephalalgia : an international journal of headache (Cephalalgia) Vol. 32 Issue 10 Pg. 750-65 (Jul 2012) ISSN: 1468-2982 [Electronic] England
• PMID: 22711898 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Serotonin Receptor Agonists
• Triazoles
• Tryptamines
• rizatriptan

Topics

• Adolescent
• Child
• Double-Blind Method
• Female
• Humans
• Male
• Migraine Disorders (drug therapy)
• Serotonin Receptor Agonists (therapeutic use)
• Treatment Outcome
• Triazoles (therapeutic use)
• Tryptamines (therapeutic use)