It is rare that a day goes by without news of an advance in medical science. If one day a cure for a life altering syndrome is discovered, it will almost certainly be the result of thousands of hours of medical research and conducting of clinical trials. Clinical trials contribute to knowledge of and progress in the fight against many diseases. Many of today’s migraine treatments are based on what we learned from clinical trials in the past, sometimes even when these treatments were being studied for reasons other than migraine. Clinical research is done when it is not known whether a new approach works safely and well in humans and also to understand which treatments or approaches might work best for certain illnesses and/or in certain groups of people.
Different types of research for different purposes
There are many different types of research that might be conducted in order to learn more about a disease or its treatment. Although there are theories as to the potential cause(s) of migraine, the true cause is basically unknown and may actually involve a combination of medical, environmental and genetic factors. Basic scientific research can help identify what factors might trigger changes in the brain that lead to painful migraines. Already, scientists know that a long list of migraine triggers, including hormones and specific foods, may cause headaches. Identifying these triggers, in addition to common migraine symptoms and the various ways migraine disease affects the body, has led to the discovery of numerous migraine drug treatments. As understanding of disease, symptoms, and triggers improves, new therapies will likely follow, and they will be evaluated in population based studies, as well as clinical trials.
Basic scientific research
Basic scientific research is essential to helping physicians understand migraine related problems like potential causes, who is likely to suffer with migraines and clues to possible treatments or even a cure. Since the cause of migraine is basically unknown, basic scientific research, usually conducted in laboratory or other controlled settings, is critical to helping physicians and patients deepen their understanding about why migraines occur. For example, researchers might explore chemical changes in the brain during a migraine or whether a person’s DNA plays a role in increasing their chances of suffering from chronic migraines.
Epidemiological studies (population based)
Epidemiology is the study of health and illness patterns at a population level. Different than clinical trials which are conducted in a more controlled environment, epidemiologic studies identify trends among groups of people, such as a common migraine symptom or type of aura and combine the information to help form an opinion. For example, numerous epidemiologic studies have attempted to assess what percentage people who experienced a stroke had a history of migraines. Basic scientific research might be attempted to learn a possible reason for a connection between migraine and stroke. Once these suggestions start to emerge, they may eventually be studied in a clinical trial to actually prove or disprove their validity.
A clinical trial is a research study, which follows a predetermined protocol or plan. The purpose of a clinical trial is to answer specific questions about new therapies such as drugs or vaccines, or new ways of using medications or treatments that have already been approved for other uses. Clinical trials are used to determine whether new drugs or treatments are both safe and effective and are part of a new drug approval process. Carefully conducted migraine clinical trials are the fastest and safest way to find treatments that work in people and they are considered the best way to answer specific questions about drugs or treatment strategies.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
Before a drug is marketed, researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
After Phase I, but before a drug is marketed, the drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
After Phases I and II and nearing the end of the pre-marketing trial process, the drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Once the drug has been marketed and is beginning to be used in larger groups of people, information is gathered on the drug's effect in various populations and any side effects associated with long-term use.
Who pays for research?
Various types of research may be sponsored or funded by a variety of organizations (such as the Migraine Research Foundation) or individuals such as physicians, medical institutions, foundations, voluntary groups. Pharmaceutical companies, as well as federal agencies such as the National Institutes of Health (NIH), the Department of Defense (DOD), and the Department of Veterans Affairs (VA) are all major funders of migraine clinical trials. Clinical trials can take place in a variety of locations, such as hospitals, universities, doctors' offices, or community clinics.
What you can do to get involved
Support for organizations or advocacy groups that support migraine research such as the Migraine Research Foundation is critical to advancing the cause for a cure. If you are considering more direct involvement by getting involved in a research trial you don’t necessarily have to be suffering from migraines. Studies often need healthy volunteers to participate in order to compare results with people who are suffering from the migraine disease who may also be participants. Many people might benefit from your involvement in migraine clinical research: your relatives, your friends and even you. Talk to your doctor or visit the government clinical trial registry to find a clinical study near you.
Visit our "Get Involved" page to Learn More about migraine advocacy and support groups