New drug for migraine in children and adolescents
A new treatment option for children and adolescents with migraine results from a drug trial with 977 patients. "The treatment options for young migraineurs are so far very limited and with one exception allowed the most effective drugs, the triptans, only be prescribed to adults," explains Professor Hans-Christoph Diener, Director of the Department of Neurology of the University Hospital Essen. The new data, published in the journal Cephalalgia, have already allowing in US approval of the drug rizatriptan and are now probably the test procedure for the EU to accelerate.
"About eight percent of all children and young people occasionally suffer from migraine attacks, and by no means all of them can be helped with painkillers such as ibuprofen and paracetamol," says Professor Florian Heinen from the German Society for Neuropediatrics, describing the dilemma. "Among the particularly effective preparations from the class of triptans, only sumatriptan nasal spray for 12 to 17-year-olds is approved in Europe," says the medical director of the neuropediatrics department at Dr. from the Hauner Children's Hospital of the Ludwig Maximilian University in Munich.
Successful differentiation from the placebo effect
Several studies on the treatment of migraine attacks in children and adolescents had previously failed, write the authors, led by David J. Hewitt, senior director at Merck Research Laboratories, which developed the study drug rizatriptan and funded the current study. The reasons given by Hewitt and colleagues are that children respond even more strongly than adults to placebo drugs and that they may also be more receptive to adults' expectations. The differences to the real drug are therefore more difficult to prove. In addition, children and adolescents in previous studies may have received insufficient amounts of active ingredient, it is said.
The “Rizatriptan Protocol 082 Pediatric Migraine Study Group” took these considerations into account with a special study design in which more difficult cases were included and fewer placebo responders were to be expected. In addition, those subjects who were allocated rizatriptan received a higher dose of 40 milligrams of the drug from a body weight of 10 kilograms and not 5 milligrams as in previous studies.
As a result, the study doctors were able to demonstrate a statistically significant difference between rizatriptan and placebo recipients for the most important target value: In the group of 12 to 17-year-olds, 30,6 percent of the test persons taking rizatriptan were pain-free two hours after the start of their migraine attacks, while only those taking placebo 22 percent. In addition, more adolescents in the rizatriptan group reported being able to go about their daily activities “as usual” after 24 hours. Nausea and vomiting occurred less frequently with the drug, and photophobia and sensitivity to noise were not affected.
The same trend as in the 12- to 17-year-olds was seen in the 6- to 11-year-olds, albeit not statistically significant: Here, 39,8 percent achieved freedom from pain within two hours with rizatriptan compared to 30,4 percent with placebo . For both groups together, the analysis revealed a ratio of 33 to 24,2 percent.
Drug was well tolerated
"Of course, we have to pay particular attention to possible side effects in children and adolescents," emphasizes Professor Heinen. In terms of tolerability, there were no significant differences between rizatriptan and the placebo within 14 days. "Moderate success was achieved in a group of children and adolescents that was comparatively difficult to treat - a practically important result without compromising on safety. An early approval of the preparation in Europe could therefore expand the possibilities of neuropediatrics if we reach our limits with conventional pharmacotherapies," says Professor Heinen.
Source:
Ho TW et al. Efficacy and tolerability of rizatriptan in pediatric migraineurs: Results from a randomized, double-blind, placebo-controlled trial using a novel adaptive enrichment design. cephalalgia. 2012 Jul;32(10):750-765.
http://www.ncbi.nlm.nih.gov/pubmed/22711898
Source: Essen [ DGN ]
