Efficacy and tolerability of rizatriptan in pediatric migraineurs: results from a randomized, double-blind, placebo-controlled trial using a novel adaptive enrichment design.
Cephalalgia
; 32(10): 750-65, 2012 Jul.
Article
em En
| MEDLINE
| ID: mdl-22711898
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 201 placeborizatriptan 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 11 to rizatriptanplacebo, 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.
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Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Triazóis
/
Triptaminas
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Agonistas do Receptor de Serotonina
/
Transtornos de Enxaqueca
Tipo de estudo:
Clinical_trials
Limite:
Adolescent
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Child
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Female
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Humans
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Male
Idioma:
En
Ano de publicação:
2012
Tipo de documento:
Article