Efficacy of zolmitriptan nasal spray in adolescent migraine
ABSTRACT 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.
SourceAvailable from: Hope L O'Brien
Article: Treatment of Pediatric Migraine[Show abstract] [Hide abstract]
ABSTRACT: The diagnosis of migraine in the pediatric population is increasing as providers are becoming more familiar with recognizing the condition. Over-the-counter and migraine-specific treatment, once considered off-label, have proven to be effective, especially if given at the early onset of head pain. Mild to severe cases of migraine should be treated with nonsteroidal anti-inflammatory drugs (NSAIDs), with triptans used alone or in combination in moderate to severe headaches unresponsive to over-the-counter therapy. Rescue medication including dihydroergotamine (DHE), a potent vasoconstrictor should be used for intractable migraines and is preferred in the hospital setting. Anti-emetics that have anti-dopaminergic properties can be helpful in patients with associated symptoms of nausea and vomiting along with headache, especially when used in combination therapy. Preventative treatment should be initiated early in patients with frequent headaches to improve headache outcomes and quality of life. Patients and families should be educated on non-pharmacologic management, such as lifestyle modification and avoidance of triggers, that can prevent progression and worsening of migraine.Current Treatment Options in Neurology 01/2015; 17(1):326. DOI:10.1007/s11940-014-0326-1 · 2.18 Impact Factor
[Show abstract] [Hide abstract]
ABSTRACT: Migraine headache is a common pediatric complaint among emergency department (ED) patients. There are limited trials on abortive therapies in the ED. The objective of this study was to apply a comparative effectiveness approach to investigate acute medication regimens for the prevention of ED revisits. Retrospective study using administrative data (Pediatric Health Information System) from 35 pediatric EDs (2009-2012). Children aged 7 to 18 years with a principal diagnosis of migraine headache were studied. The primary outcome was a revisit to the ED within 3 days for discharged patients. The primary analysis compared the treatment regimens and individual medications on the risk for revisit. The study identified 32 124 children with migraine; 27 317 (85%) were discharged, and 5.5% had a return ED visit within 3 days. At the index visit, the most common medications included nonopioid analgesics (66%), dopamine antagonists (50%), diphenhydramine (33%), and ondansetron (21%). Triptans and opiate medications were administered infrequently (3% each). Children receiving metoclopramide had a 31% increased odds for an ED revisit within 3 days compared with prochlorperazine. Diphenhydramine with dopamine antagonists was associated with 27% increased odds of an ED revisit compared with dopamine antagonists alone. Children receiving ondansetron had similar revisit rates to those receiving dopamine antagonists. The majority of children with migraines are successfully discharged from the ED and only 1 in 18 required a revisit within 3 days. Prochlorperazine appears to be superior to metoclopramide in preventing a revisit, and diphenhydramine use is associated with increased rates of return. Copyright © 2015 by the American Academy of Pediatrics.
[Show abstract] [Hide abstract]
ABSTRACT: Post-traumatic headache is one of the most common symptoms occurring after mild traumatic brain injury in children. This is an expert opinion-based two-part review on pediatric post-traumatic headaches. In part II, we focus on the medical management of post-traumatic headaches. There are no randomized controlled trials evaluating the efficacy of therapies specifically for pediatric post-traumatic headaches. Thus, the algorithm we propose has been extrapolated from the primary headache literature and small noncontrolled trials of post-traumatic headache. Most post-traumatic headaches are migraine or tension type, and standard medications for these headache types are used. A multifaceted approach is needed to address all the possible causes of headache and any comorbid conditions that may delay recovery or alter treatment choices. For acute treatment, nonsteroidal anti-inflammatories can be used. If the headaches have migrainous features and nonsteroidal anti-inflammatories are not effective, triptans may be beneficial. Opioids are not indicated. Medication overuse should be avoided. For preventive treatments, some reports indicate that amitriptyline, gabapentin, or topiramate may be beneficial. Amitriptyline is a good choice because it can be used to treat both migraine and tension-type headaches. Nerve blocks, nutraceuticals (e.g. melatonin), and behavioral therapies may also be useful, and lifestyle factors, especially adequate sleep hygiene and strategies to cope with anxiety, should be emphasized. Improved treatment of acute post-traumatic headache may reduce the likelihood of developing chronic headaches, which can be especially problematic to effectively manage and can be functionally debilitating. Copyright © 2014 Elsevier Inc. All rights reserved.Pediatric Neurology 10/2014; DOI:10.1016/j.pediatrneurol.2014.10.015 · 1.50 Impact Factor