Participate in Research
What is a clinical trial?
Treatments cannot advance without clinical trials. Clinical trials are necessary to test the effectiveness of new therapies and to develop better ways of using known treatments. In some cases, they can make the difference between life and death for patients or a significantly improved quality of life.
To this end, those with epilepsy are in a special position to help others through participating in medical research that can lead to effective treatments.
Participating in a clinical trial, however, is a significant commitment and one should always have a good understanding about the study and clinical trials in general before any agreement is made.
The National Institute of Health's website will help you gain a broad understanding of clinical trials. Learn possible benefits and pitfalls of clinical trials, what questions you should ask before participating, as well as the fundamental steps involved in clinical experiments.
How can you get involved?
We provide access to two lists of current research studies in epilepsy recruiting volunteers: clinicaltrials.gov and CenterWatch.
These lists represent only a small amount of epilepsy studies seeking volunteers. To find out about other studies, you can look for advertisements in newspapers or trade journals. Your own health care provider may be conducting research for which you are eligible or may know of other studies looking for volunteers. If you do a search on the internet, you will find that many medical sites have email lists you can join to be notified of available studies.
Pregnant women with epilepsy who are taking antiepileptic drugs can help researchers learn how certain drugs affect unborn children by participating in the Antiepileptic Drug Pregnancy Registry.
Participate in epilepsy research and help to develop improved treatments and find a cure!
The following are current studies that are being conducted. Contact the research study staff directly for the most current information.Surgery for the Treatment of Epilepsy
People 8 years of age or older with seizures that are not controlled by medication are needed for a research study (Protocol 11-N-0051) whose purpose is to evaluate patients with seizures that cannot be controlled with medication and to provide epilepsy surgery. People will be evaluated with standard testing, including magnetic resonance imaging (MRI) of the head, blood tests, video electroencephalography (vEEG), and neurological examinations. If surgery is indicated, the person will be admitted to the NIH Clinical Center for about 2 weeks for surgery and recovery. People will return for outpatient visits 2, 12 and 24 months after surgery. There is no charge for study-related tests and procedures; some travel costs may be reimbursed. Contact the Patient Recruitment and Public Liaison Office at NIH (800) 411-1222 or Federal Relay TTY (866) 411-1010. More information can be found at http://www.clinicaltrials.gov/ct2/show/NCT01273129?term=epilepsy+surgery&rank=5. This study is sponsored by the National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health, Bethesda, MD.
Women with Epilepsy: Pregnancy Outcomes and Deliveries (WEPOD) Study - RECRUITING
The purpose of this research study is to see if it is more difficult for women with epilepsy to become pregnant than healthy women without epilepsy, and to compare seizure frequency in women with epilepsy before and during pregnancy. Key Inclusion Criteria: women between ages 18 and 40 who are planning pregnancy and have stopped or planning to stop birth control. Key Exclusion Criteria: use of hormonal therapies for contraception, diagnosis of infertility, diagnosis of polycystic ovary syndrome.
This study is open for recruitment at the following locations: Brigham and Women's Hospital, Boston, MA. Principal Investigator: Page Pennell, MD (617-732-7547 / firstname.lastname@example.org). Study Coordinator: Nichelle Llewellyn (617-732-5423 / email@example.com). Long Island Jewish Medical Center, New Hyde Park, NY. Principal Investigator: Cynthia Harden, MD (718-470-7310 / firstname.lastname@example.org). Study Coordinator: Connie Lau, MS, CCRC (718-470-7074 / email@example.com). New York University School of Medicine, New York, NY. Principal Investigator: Jacqueline French, MD (646-558-0868 / Jacqueline.firstname.lastname@example.org). Study Coordinator: Benjamin Kaufman (646-558-0843 / email@example.com). This study is also posted on clinicaltrials.gov: http://clinicaltrials.gov/ct2/show/NCT01259310
Epilepsy Birth Control Registry
Despite the importance of birth control to women of reproductive age, there has been little formal investigation of the safety and effectiveness of birth control methods in women with epilepsy. To remedy this, doctors from Harvard and Columbia University Medical Schools have developed a website that offers a survey to help us gain more knowledge and some educational material that will be updated regularly to provide the latest information. The ultimate goal is to develop guidelines for the selection of safe and effective birth control methods and to make sure that the best forms of birth control become available to women with epilepsy in all communities of our society. Go to www.epilepsybirthcontrolregistry.com, take the survey and then catch up on the latest information about birth control for women with epilepsy.
Evaluation and Treatment of Patients With Epilepsy
This study has three purposes: 1) to screen patients with seizures for participation in research studies of NINDS's Clinical Epilepsy Section (CES), 2) to follow the natural course of seizure disorders and 3) to train CES fellows in evaluating and treating epilepsy. Only standard diagnostic tests and treatments will be used in this study. Patients of any age with seizures who are referred to CES may participate in this study. At the end of the study, patients may be discharged to the care of their referring physician, offered participation in another NINDS research study, or followed for teaching purposes. Contact Patient Recruitment and Public Liaison Office at NIH (800) 411-1222 firstname.lastname@example.org.
Family Studies in Epilepsy
Under the direction of David A. Greenberg, PhD, at Columbia University, this research is being conducted to determine the causes of inherited forms of epilepsy. Study participation takes less than two hours and includes completion of the consent form, family interviews to collect clinical history and a saliva sample from each participant. For more information, call 212-342-0481 or visit the study website www.geneticsofepilepsy.org.
Update on previous studies
ROSE (Radiosurgery or Open Surgery for Epilepsy) - ONGOING, NOT RECRUITING PARTICIPANTS
Epilepsy surgery is an alternative for some people whose seizures cannot be controlled by anticonvulsant medications. Radiosurgery is a minimally-invasive radiation procedure used to treat tumors and other abnormalities of the brain, and is currently being investigated as an alternative to open surgery treatment alternative for a very select group of patients with medically refractory partial epilepsy. The Gamma Knife® radiosurgery instrument used in this study uses tightly focused beams of radiation to injure the surgical target, rather than removing it with open surgery. Gamma Knife radiosurgery does not require an inpatient hospital stay. Currently, there is a trial sponsored by the National Institutes of Health and Elekta, the company that manufactures the Gamma Knife, that is designed to compare advantages and disadvantages of open surgery versus radiosurgery. The ROSE Trial (Radiosurgery or Open Surgery for Epilepsy) is being conducted in major epilepsy centers across the US and Canada.
To view participating centers and for more information about this trial, ask your neurologist or epileptologist or visit the following websites: http://www.clinicaltrials.gov/ct2/show/NCT00860145?term=radiosurgery+and+epilepsy&rank=1 or http://neurosurgery.ucsf.edu/index.php/clinical_trials_epilepsy.html
Epilepsy Phenome/Genome Project - AS OF DECEMBER 2012, ENROLLMENT IN THE STUDY IS COMPLETE.
The Epilepsy Phenome/Genome Project (EPGP) is the largest research study ever created to identify genes that influence epilepsy and genes that affect an individual's response to seizure medications. The National Institutes of Health is partnering with major epilepsy centers around the country in order to understand what causes epilepsy, which treatment will be effective, and why some families have multiple relatives with seizures. For future information about research findings and long-term follow-up with participants, please visit www.epgp.org.
Extended Release Topiramate Study
A new study for USL255 (extended-release topiramate) is on-going, but not recruiting participants. This new formulation of the drug is designed to provide convenient once-daily dosing and reduce fluctuations in topiramate blood levels observed with currently available topiramate options. It will be a new treatment option with the potential for improved medication compliance. The study will evaluate the effectiveness and safety of USL255 in patients 18 to 75 years of age with refractory partial-onset seizures. Visit the study's clinicaltrials.gov page for more information.
Contact: Mitch Herndon (877) 352-4505
For more information on clinical trials visit http://www.clinicaltrials.gov/ct2/results?term=epilepsy
*This listing of epilepsy studies is for information purposes only; and the reader assumes full responsibility and risk for the appropriate use of the information provided. The information concerning the study was sent to the Epilepsy Foundation by the investigator or staff conducting the research. The Epilepsy Foundation, its affiliates, officers, directors, employees and agents do not warrant or guarantee the accuracy or completeness of this information and specifically disclaims any liability therefore.