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Cephalalgia. 2012 Jul;32(10):750-65. Epub 2012 Jun 18.

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

Collaborators (264)

McKhann G, Eliasziw M, Fisher PG, Tennekoon G, Hsu DT, Nassogne MC, Sekhara T, Almadani M, O'Mahony M, Richer L, Illum N, Laugaard-Jacobsen HC, Sander V, Talvik I, Kallela M, Keski-Santti P, Kiukkonen J, Nikkanen E, Nissila M, Partinen M, Peltola J, Annequin D, Cuvelier JC, Fournier-Charriere E, Laborde S, Milh M, Navez ML, Parain D, Suc A, Ebinger F, Evers S, Gaul C, Gendolla A, Jansen JP, Laengler K, Pothmann R, Schellenberg R, Agarwal S, Anand I, Chandran S, Chodhary VB, Harawat PJ, Harsha S, Jog P, Kannan A, Karardan U, Keerthi AS, Nellikunja S, Pandit L, Srinivasa R, Barbanti P, Jegere D, Strautmanis J, Mulleners W, Pop P, Van den Berg P, Bryn B, Kjaernli T, Sommerfelt K, Kochanowska I, Pietrzak M, Strzelecks J, Szatanik M, Wesolowska M, Benga I, Craiu DC, Diaconu G, Gheonea C, Popescu L, Artigas Pallares J, Blanco Barca O, Campistol Plana J, Macaya A, Mosquera Villaverde Mdel C, Reyes Martin A, San Antonio MV, Danielsson B, Ohrner Y, Arthur CP, Bala P, Gardner S, Gosalakkal J, Prabhakar P, Abrahim A, Adler L, Aguado M, Atalla A, Atri PB, Aurora S, Baber R, Banks JW, Bargar R, Barker J, Barrington P, Bateman L, Baur CE, Bays H, Bennett NL, Berenson FR, Berman GD, Berstein A, Bhatia P, Blumenfeld A, Bramlet D, Broker RE, Byrd S, Cady R, Calcagno J, Camacho A, Carlini W, Casadonte J, Choi S, Christensen SG, Civitarese F, Clark WD, Corder CN, David R, Dhaduk V, Duffy CA, Earle R, Edmond M, Edrozo J, Eross E, Erwin JS, Espinosa-Paccini JB, Essink B, Farmer M, Fedlman M, Fermando M, Fieve RR, Fisher M, Flitman S, Ford LB, Forner SD, Fox E, Frandsen B, Fry JA, Fuller GR, Gaffney ME, Gasecki A, Gay C, Gelfand S, Giancarlo T, Giblin J, Glover MC, Goldstein G, Goodman H, Gordon G, Gorrela SV, Grainger W, Gray J, Gupta P, Halthore SN, Handal NM, Harris DJ, Harvey B, Hazan L, Hedrick J, Henry DC, Herring MO, Hines RL, Holloway W Jr, Horwitz AE, Huling R, Igleburger J, Jennings W, Jones T, Julien KA, Katie A, Kent EF, Khan A, Khan A, Kimmel MA, Klein TR, Knutson J, Krafty MB, Kratzer J, Kwentus J, Lacey D, Lane P, Lebron D, Lesh K, Ley J, Linder S, Liu E, Luber SR, Machanic B, Marcadis I, Markely HG, Markovitz PJ, Mate LJ, Mathew NT, McAllister P, McGettigan JW, Means P, Mechtler L, Mehra V, Melamed I, Miller DC, Miller JL, Miranda F, Moon M, Muhar IM, Munoz S, Murphy K, Nanavaty R, Nayak NA, Nelson J, Nett R, Neufeld N, Nussdorfer T, O'Carroll C, Oftadeh L, O'Hern R, Onder R, O'Reilly T, Palanpurwala K, Pathak L, Pearlman EM, Pendleton J, Peterson R, Poy IG, Qaqundah P, Renfroe J, Richer R, Riesenberg R, Robbins L, Roberts KL, Rothner DA, Salem G, Samudrala S, Saper JR, Sarkis E, Saunders M, Schaerf F, Schreiber AO, Sebastian V, Sedill A, Silas PE, Silverboard G, Sivakumar K, Smietana S, Snell P, Sperling M, Spiegel C, Spierings E, Stedman M, Stepp WP, Strzinek R, Taber LM, Taghadosi M, Taylor L, Thurman LM, Ventre P, Wade RD, Wagner A, Weissman JD, Williams D, Wilson MC, Wisman P, Wolfson E, Woodruff BE, Wyszomierski DA, Zinn MM.

Author information

  • 1Merck Sharp & Dohme Corp., North Wales, PA, USA.

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.

PMID:
22711898
[PubMed - indexed for MEDLINE]
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