New OptiNose Migraine Treatment Shows Promise in its Phase III Clinical Trial
OptiNose.com (Breath-powered Delivery System)
OptiNose US Inc. announced in November that the phase III study of its new device for delivering migraine medication was successful. This device, which delivers low-dose sumatriptan via the nose with OptiNose Bi-Directional™ nasal technology, provided headache relief for 68% of patients with moderate to severe migraine after two hours. The trial found patients began to experience headache relief as quickly as 15 minutes after administration, with nearly 42% reporting pain relief at 30 minutes post-treatment, according to a company press release.
Roger K. Cady, MD, Director of the Headache Care Center in Springfield, Missouri, and Associate Executive Chairman of the National Headache Foundation, expressed his feelings about the study and the potentially new delivery method.
“There are 30 million migraine sufferers in the US alone, and many of these sufferers, despite current treatments, are dissatisfied and continue to search for new treatments that provide fast and effective migraine relief,” he said. “The treatment tested in this trial uses OptiNose technology to deliver a surprisingly low dose of a proven medicine in a unique, new way. We found the treatment provided pain relief quickly and with few adverse events. Rapid relief can be very important in this condition where symptoms often come on fast and can be very debilitating.”
Study of OptiNose technology is ongoing. See www.optinose.com for more information about the device and to participate in the company’s research.
A study from The Netherlands has found that women develop brain lesions more often than their counterparts without migraine. And while this may sound worrisome, researchers believe that those changes are not clinically significant and do not appear to be linked to dementia or other types of cognitive decline.
“Patients should not live with the idea that each migraine attack is potentially ‘damaging’ their brains,” researcher Mark Kruit, M.D., Ph.D., told Time magazine. “Patients should know that the [volume] of changes is small, and they are not related to worse cognitive function. There is no need for change in the way migraine patients are treated, based on the study results.”
National Headache Foundation Board President Arthur Elkind, M.D., stressed that migraineurs should not be alarmed about these most recent findings, as such lesions have been noted for decades with no clinical significance, and they have been noted in other neurological disorders, as well.
For this study, which began in 2000, researchers at Leiden University Medical Center performed MRI brain scans on the nearly 300 participants, mostly migraine sufferers. In 2009, they repeated the brain imaging tests and compared the changes in brain lesions in those with and without migraine.
In men, researchers found no difference; males with and without migraine had the same likelihood of having these lesions, called hyperintensities.
In women, however, the differences were striking. During the nine years between scans, the lesions progressed in 77% of the women with migraine compared to 60% of the control group. Researchers also found that the growth of the lesions, which they likened to scars on the brain, was not affected by the severity or frequency of migraine attacks or to the presence of an aura, but to the root cause of migraine itself.
The authors, led by Inge Palm-Meinders, M.D., also noted that these hyperintensities found in the brain’s white matter—or connective tissue—could stem from changes in small blood vessels, and that tending to other risk factors, such as obesity, smoking, hypertension and physical exercise may be especially wise for migraineurs.
Further study in this area is warranted to better understand the lesions and gain insight into the pathology of migraines and how best to treat them.
This article appeared in a recent issue of the Journal of the American Medical Association.
While some people may think that migraine research involves sophisticated lab equipment and advanced brain scans, a group of researchers based in Boston recently took a different route. They turned to Google and Twitter—which provide information from millions of people across the globe—to see what online activities could tell them about migraine.
After studying Google activity spanning from January 2007 through July 2012, researchers learned that the beginning of the work week is the most common time for people to do a migraine-related Google search, with the most searches appearing at 7 a.m. on Tuesdays and dropping to a low point on Fridays. Weekends and holidays also ranked low on the list of migraine-related online searches. The authors noted these findings matched earlier research indicating people experience fewer migraines on days off.
Results for Twitter showed similar findings, with Monday ranking highest for mention of migraine and Friday the least. This, too, is consistent with earlier research that showed migraine attacks peak between 6 and 8 a.m., the researchers said.
Tweets about headache in general also peaked about 7 a.m. during the work the week and at 9:30 a.m. on weekend mornings. Headache was tweeted about significantly more than migraine, and women far outnumbered men in their tweets.
Lead author Clas Linnman of Boston Children’s Hospital, noted the findings were not a surprise to him. “People will get more migraines when they are stressed,” he told Boston.com, which reported on the study.
A deeper look at the findings showed that typically people searched for information on migraine symptoms, triggers, treatments and duration.
Arthur Elkind, M.D., the president of the NHF Board of Directors, expressed a word of caution about this study’s findings, however.
“Assuming that the individuals suffered from tension-type headache might lead to some error,” he said. “Migraine in many sufferers also occurs on weekend or holidays, which one would consider as periods of relaxation and less stress. They may be unable to search online until the attack has completely abated, and that may be on the weekday.”
The article appeared in a recent issue of Cephalalgia.
Children with migraine tend to perform less well in school than their peers, according to a new study from Brazil.
In 87 Brazilian cities, researchers evaluated nearly 5,700 children between ages 5 and 12 by collecting information from the students’ teachers and parents. Results indicated that 9% of the children experienced episodic migraine (migraine less than 14 days per month), nearly 18% experienced probable migraine and less than 1% experienced chronic migraine (migraine 15 or more days per month).
Students with both episodic and chronic migraine performed less well in school than their peers without headache. In fact, those with migraine were 30 percent more likely than their healthy peers to perform below average in school. Migraine’s severity, frequency and duration also correlated with poor academic performance, as did abnormal mental health scores and the use of analgesics.
Findings from the study underline the importance of this issue and obtaining appropriate medical treatment, as better school performance in the early years has been linked to better high school and college performance, which in turn may lead to more opportunities later in life.
“With approximately one-fourth of school-age children having headaches with migraine features, this is a serious problem, especially for those with frequent, severe attacks that do not subside quickly,” said one of the researchers, Marcelo Bigal, M.D., Ph.D., a neurologist at the Albert Einstein College of Medicine in Bronx, NY. “Parents and teachers need to take these headaches seriously and make sure children get appropriate medical attention and treatment.”
Lead author of the study was Marco Arruda, M.D., Ph.D., of the Glia Institute in Brazil, Merck and Co. and the Albert Einstein College of Medicine. The study appeared in a recent issue of Neurology.
Office workers in buildings with poor quality indoor air suffer from more intense migraines and more severe headaches than those who work in buildings with good air quality, a new study has found.
Researchers from the University of Toledo, Ball State University and Virginia Tech teamed up to better understand the connection among migraine, headache and indoor environmental parameters, such as the levels of carbon monoxide and dioxide, particulate matter and volatile organic compounds as well as temperature and humidity. They evaluated data from a study that the U.S. Environmental Protection Agency conducted of 100 offices in 25 states from 1994 to1998. More than 4,300 workers participated.
In all, the researchers found that when the participants worked in an environment with unhealthy indoor air, 38% reported experiencing a headache one to three days per month, and 8% reported headache on a daily basis.
According to a press release from Ball State University, when exposed to an uncomfortable air environment, researchers found the following:
- Females were more likely to report a headache in the last four weeks than males (75% vs. 53%).
- About 21% of employees reported that a physician had diagnosed them with migraine. Females (27%) were significantly more likely than males (11%) to report a migraine diagnosis.
- The highest levels of migraine diagnosis were for employees exposed to out-of-comfort range levels of carbon monoxide and carbon dioxide in their office buildings.
- Exposure to out-of-comfort range indoor environmental parameters was higher in groups that reported higher headache frequencies.
The authors note that the issue of air quality in many building types was first described after the oil shortage in the 1970s, when buildings began to be constructed to be airtight and entirely dependent on artificial heating, ventilation and air-conditioning (HVAC) systems. Sometimes these systems are not properly maintained or operated, resulting in further air quality issues, and the authors advise building managers to create and implement strategies to improve indoor air quality.
“Collection of periodic data on indoor environmental parameters should become a universal practice, and based on the data, a health risk management plan for the occupants should be designed,” said Suchismita Bhattacharjee, one of the authors from Ball State University. “Reviewing operation and maintenance of heating, ventilation and air conditioning systems should be made an integral part of the strategies to reduce harmful worksite exposures.”
Neurologist Gretchen E. Tietjen, MD, of the University of Toledo Medical Center, led the study, which appeared in the Annals of Indian Academy of Neurology.