Efficacy of Zolmitriptan Nasal Spray in Adolescent Migraine

Division of Pediatric Neurology, Children's Hospital of the King's Daughters, Eastern Virginia Medical School, Norfolk, VA 23510, USA.
PEDIATRICS (Impact Factor: 5.47). 08/2007; 120(2):390-6. DOI: 10.1542/peds.2007-0085
Source: PubMed


The goal was to evaluate the efficacy and tolerability of zolmitriptan nasal spray in the treatment of adolescent migraine.
The "Double-Diamond" study used a novel, single-blind, "placebo challenge" in a multicenter, randomized, double-blind, placebo-controlled, 2-way, 2-attack, crossover design. A total of 248 US adolescent patients (12-17 years of age) with an established diagnosis of migraine, with or without aura, were enrolled. A single-blind placebo challenge was used for each migraine attack. No additional medications were taken if a headache response to the initial placebo treatment was achieved at 15 minutes; if migraine intensity remained moderate or severe, then patients treated the attack with zolmitriptan (5 mg) nasal spray or placebo according to a randomized, crossover schedule (double-blind). The primary efficacy variable was headache response at 1 hour after treatment. A comprehensive range of secondary end points included sustained headache response at 2 hours.
A total of 171 patients (mean age: 14.2 years; 57.3% female) treated > or = 1 attack with study medication (intention-to-treat population). The onset of significant pain relief was apparent 15 minutes after treatment with zolmitriptan nasal spray. At 1 hour after the dose, zolmitriptan nasal spray produced a higher headache response rate than did placebo (58.1% vs 43.3%). Zolmitriptan nasal spray was also significantly superior to placebo in improvement in pain intensity, pain-free rates, sustained resolution of headache, and resolution of associated migraine symptoms. Return to normal activities was also consistently faster with zolmitriptan nasal spray than with placebo, with less use of any escape medication. Treatment with zolmitriptan nasal spray was well tolerated.
This novel, placebo-challenge study demonstrated that zolmitriptan nasal spray was well tolerated and provided fast and significantly effective relief of migraine symptoms in the acute treatment of adolescent migraine.

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    • "Domperidone is the only antiemetic drug licensed for use in children up to 12 years of age (Evers et al. 2009). 3. Moderate to severe migraine crisis in teenagers over 12 years old can be managed with sumatriptan (Winner et al. 2000; Curran et al. 2005; Cady and Schreiber 2006; Evers et al. 2009, Pereira-Monteiro 2009; Goldman and Meckler 2015), rizatriptan (Ahonen et al. 2006) or zolmitriptan (Evers et al. 2006; Lewis et al. 2007) and the efficacy of these drugs has been supported by moderate to high quality evidence. The off-label use of triptans is still a matter of debate, however more recently sumatriptan nasal spray and zolmitriptan nasal spray have been approved for adolescents in Europe; almotriptan has been approved for adolescents in the USA, as has rizatriptan for patients aged 6–17 years (Wöber-Bingöl 2013). "
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    ABSTRACT: This clinical vignette presents a 14 years old female, with a past medical history relevant only for migraine with typical aura of less than monthly frequency, complaining of a severe unilateral headache with rising intensity for the previous 4 h, associated with nausea, vomiting, photophobia and phonophobia. This episode of migraine with aura in a patient with recurrent migraine was complicated by side effects of medical diagnostic and therapeutic procedures (extrapyramidal symptoms, delirium, post-lumbar puncture headache, hospital admission) all of which could have been prevented-quaternary prevention. This case illustrates several important messages in migraine management: (1) use of acetaminophen is not based in high-quality evidence and better options exist; (2) among youngsters, domperidone should be preferred over metoclopramide because it does not cross the blood-brain barrier; (3) moderate to severe migraine crisis can be managed with triptans in teenagers over 12 years old; (4) it is important to recognize adverse drug effects; (5) harmful consequences of medical interventions do occur; (6) the school community must be informed about chronic diseases of the young.
    SpringerPlus 08/2015; 4(1):409. DOI:10.1186/s40064-015-1206-1
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    • "Zolmitriptan also produced a significant pain-free response at 1 h (27.7 vs. 10.2% in the placebo group, P < 0.001), proving to be significantly superior to placebo in improving pain intensity, pain-free rates, sustained resolution of headache and resolution of associated migraine symptoms. Treatment with zolmitriptan NS was well tolerated [24]. "
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    ABSTRACT: There is a serious lack of controlled studies on the pharmacological treatment of primary migraine in the developmental age; there is, consequently, an urgent need for new, evidence-based approaches to this long-neglected field of research. Moreover, previous studies have stated that the placebo response is greater in pediatric patients than in adults and that a reduction in the attack frequency in the absence of any pharmacological treatment is observed more frequently in pediatric migraine patients than in adults. Besides these preliminary considerations, the shorter duration of migraine attacks and other characteristic semeiological features of the clinical picture in children are such that the design of randomized controlled trial (RCT) is more problematic in the developmental age than in the adult. Bearing in mind all these weak points, the aim of this review was to summarize and update recent guidelines for the treatment of primary migraine in children and adolescents. The most recent guidelines are those published by the Italian Society for the study of Headache, the French Society for the study of Migraine and Headache, and the American Academy of Neurology. We have incorporated into these guidelines the results from the few, recent RCTs, clinical controlled trials, open-label studies, meta-analyses and reviews that have been published since 2004; owing to the lack of strong evidence in this field of research, we have sometimes even mentioned pilot non-controlled studies, case series and expert opinions. Lastly, evidence was classified and the recommendations were categorized according to different levels.
    The Journal of Headache and Pain 03/2010; 11(3):267-76. DOI:10.1007/s10194-010-0205-4 · 2.80 Impact Factor
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    • "In this trial, a 100-mg daily dose, but not a 50-mg daily dose, was found to be more effective than placebo for reducing rates of migraine headaches. For acute treatment of migraines, zolmitriptan nasal spray was studied in adolescents with a known diagnosis of migraine, with or without aura [93]. At 1 hour after dosing, relief was seen by 58% of zolmitriptan-treated participants compared with only 43% of those treated with placebo for acute headache, and both pain reduction and sustained relief were better in the active drug arm. "

    Advances in Pediatrics 01/2010; 57(1):163-83. DOI:10.1016/j.yapd.2010.08.004
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