News and Information

The News and Information section of the Epilepsy Institute's web site will be updated on a regular basis to provide you with information about the latest events concerning epilepsy in NYC, the latest information on clinical trials at the Comprehensive Epilepsy Centers in NYC, and new treatment information. Click on the topic below to find out more information.

CLINICAL TRIALS

UPCOMING EPILEPSY EVENTS IN NYC

LATEST NEWS ABOUT EPILEPSY

CLINICAL TRIALS

Investigational Drug Trials
After a new medication is shown to be safe through extensive testing on animals, it is tested for long-term safety and effectiveness on people. These are known as Investigational Drug Trials. All trials are approved by the FDA and are closely supervised by epilepsy center staff, the company providing the medication, and the FDA. Most investigational drug trials provide free comprehensive care for the patients involved, including free laboratory tests and studies, doctors' visits, travel compensation and study medications. Patients enrolled in an investigational study receive careful medical supervision and follow-up.

New York University Comprehensive Epilepsy Center
The NYU Comprehensive Epilepsy Center is currently enrolling patients (ages 4-65) with Primary Generalized Epilepsy to study the safety and effectiveness of Levetiracetam who remain inadequatelly controlled. For more information and to determine eligibility, call the Clinical Trials Dept. at 212-263-8359. (Date approved - 10/18/2002)

New York University Comprehensive Epilepsy Center
The NYU Comprehensive Epilepsy Center is currently enrolling children (ages 1 month to <17 years of age) with epilepsy to study the effectiveness of an investigational medicine in this pediatric age group with inadequately controlled partial onset seizures. Hospitalization is required. For more information and to determine eligibility, call the Clinical Trials Dept. at 212-263-8359.

Beth Isreal Comprehensive Epilepsy Center
Beth Israel Comprehensive Epilepsy Center is currently enrolling persons with epilepsy to study Trileptal and Lamictal. Please call 212-870-9362 for more information.

Cornell Medical Center
The Comprehensive Epilepsy Center at Cornell Medical Center is currently enrolling children with epilepsy to study Keppra (leviteracetam) and the effect of anti-epileptic medications on mood and cognitive effects. Call 212-746-2359 for more information.

Columbia University Comprehensive Epilepsy Center
This study is designed to evaluate the stafety of Zonisamide beginning at a lower dose than that commercially available. Patients must have a diagnosis of epilepsy and required addition of zonisamide in the judgement of their treating physician. Ony patients 18 years of age or older will be enrolled at this site. Contact Deborah Schauer, R. N. at (212)305-6951 for more information.

Columbia is participating in a multicenter study designed to evaluate the efficacy and safety of Pregabalin as add-on therapy in patients with inadequately controlled partial seizures, with or without secondary generalization. Eligible patients include men and women age 18 or older, with a body weight of at least 50 kg, who have failed to achieve satisfactory seizure control on standard AEDs. Contact Deborah Schauer, R. N. at (212)305-6951 for more information.

Montefiore Epilepsy Management Center
Montefiore Comprehensive Epilepsy Management Center is currently enrolling persons with epilepsy to study Lamictal for ages 6 - 24 months, Kepra for ages 4 - 12 years, and Pregabilin for adults. They will soon be opening a trial of Zonisamide in children soon. Please call 718-920-4378 if you have any questions.

General Clinical Trials

Columbia University Comprehensive Medical Center
Reproductive Function Study - Principal Investigator: Martha Morrell, M.D.
Women with epilepsy (WWE) have high rates of infertility, reproductive disorders and gynecological conditions such as polycystic ovaries. The Reproductive Function Study is a multiyear effort to examine the effect of seizures and seizure medications on reproductive function. This study is identifying the impact of epilepsy on reproductive health, the risks posed by individual AEDs, and the best means to diagnose reproductive health disorders. Eligibility requirements include women with epilepsy from the ages of 18-40 on a single antiepileptic drug. For more information call Sylvia Done at (212)305-1936.

Bone Health Study - Principal Investigator: Martha Morrell, M.D.
Health professionals have known since the 1960s that certain antiepileptic drugs are associated with disorders of bone metabolism in both adults and children. This study will determine how particulare AEDs impact bone health in women with epilepsy and will lead to the development of prevention and treatment threapies. Eligibility requirements include women with epilepsy from ages of 18-40 on a single antiepileptic drug. For more information call Sylvia Done at (212)305-1936.

Neurodevelopmental Effects of Antiepileptic Drugs (NEAD) - Principal Investigator: Martha Morrell, M. D. The primary objective of this study is to differentiate the relative risks and benefits of three commonly prescribed AEDs in the treatment of women with epilepsy in terms of their children's neurobehavioral development after in utero exposure. The results of this study will impact the clinical management of women receiving these medications, and improve the health of their children. For more information call Sylvia Done at (212)305-1936.

Memory and Epilepsy Study - Lawrence Hirsch, M. D.
Memory dysfunction is a common and quite disabling in patients with epilepsy. Memory deficits may be due to seizures, antiepileptic drugs, or a primary underlying dysfunction of brain regions important for memory in patients with epilepsy. The purpose of this study is to determine whether the drug donezepil can improve memory function in patients with epilepsy. Donezepil is FDA approved and primarily used for patients with Alzheimer's Disease. For more information call Sylvia Done at (212)305-1936.

New York University Comprehensive Epilepsy Center
Exercise and yoga may help reduce seizures as well as relieve anxiety and depression. Dr. Steven Pacia of the NY Conmprehensive Epilepsy Center is conducting a research study on the effects of exercise and/or yoga on seizure frequency, anxiety, and depression. If interested, please contact the NYU Comprehensive Epilepsy Center at (212)263-8875

NY Presbyterian Hospital - Weill Medical College:
Volunteers Needed for an Imaging Brain - Mind Function in Epilepsy.
Participants will be reimbursed $100 for their time and effort.
FOR: Functional imaging studies of brain activity in people with EPILEPSY
INVOLVES: Interviews, brain scanning with functional magnetic resonance imaging (fMRI) (up to 3 hours), maximum total time approximately 10 hours
MUST BE: 18-75 years old, either depressed or not depressed, no serious medical or neurological conditions except epilepsy, no alcohol or substance
abuse.
CONTACT: Tracy Butler, M.D. At (212) 746-3766

NY Presbyterian Hospital - Weill Medical College:
The following three studies are for patients who are not on medicines for psychosis, but depression treatment is OK. Patients should not have a progressive brain disease, such as a brain tumor.
FOR: RWJ-33369 for partial epilepsy with and without secondary generalization. This is to study a Broad Spectrum antiseizure medicine with unkown mechanism
SPONSOR: Johnson & Johnson
INVOLVES: Two-month baseline, three months double-blind phase, then open-label. Can be on up to two antiseizure medications. Can Have VNS.
Having approximately three seizures per month

FOR: Runfinamide for partial epilepsy with and without secondary generalization. This is to study a Broad Spectrum antiseizure medicine with unkown mechanism
SPONSOR: Eisai
INVOLVES: Two-month baseline, three months double-blind phase, then open-label. Can be on up to two antiseizure medications. Can Have VNS.
Having approximately three seizures per month

Columbia University Studies

DEPAKOTE VS. DEPAKOTE ER AND TREMOR                Compensation

► Age 18-70; Currently taking regular Depakote (not Depakote ER); Tremor $150

Please contact: Hiba (Room 706; 5-3949; harif@neuro.columbia.edu) or Alicia Floyd (5-1331; afloyd@neuro.columbia.edu).

■ Subjects will take Depakote DR for 8 weeks and Depakote ER for another 8 weeks. There are 3 testing sessions where muscle activity is measured, blood is drawn, and a physical exam is preformed.

EPILEPSY AND LANGUAGE   $15/hr

►Age 18-65; Native English Speaker OR learned English before age 5

Please contact: Kim (Room 703; 5-1801; kkozma@neuro.columbia.edu).

■ The study consists of approximately 2 hours of interesting paper and pencil and computer tasks. 

GENETICS OF AUDITORY EPILEPSY

►Idiopathic or cryptogenic epilepsy; Ictal auditory symptoms or aphasia; With OR without family history of epilepsy   None  

Please contact Kay Kamberakis (5-9188; kk765@columbia.edu).

■ Participation in the study involves at least 2 telephone interviews each lasting 30 to 60 minutes, donation of a small blood sample, review of medical records, and permission to contact some relatives to invite them to participate.

PATIENT PREFERENCE STUDY

►Has had TLE surgery; Has the cognitive ability to complete questionnaires with minimal assistance       $75

Please contact Shefali (Room 703; 5-1617; ssharma@neuro.colukmbia.edu).

■ Study participation consists of completing 3 questionnaires and using a computer program to answer questions about epilepsy surgery outcomes. These tasks will take about 2 hours.

PREGABALIN INSOMNIA STUDY

►Age 18-50, 2 or fewer seizures per month, stable AEDs, complaint of insomnia without other definite sleep disorders $600

Please contact Shefali (Room 703; 5-1617; ssharma@neuro.colukmbia.edu).

■Study participation lasts for 7 weeks and involves a physical exam, completing questionnaires, keeping a sleep and seizure diary, and having 3 overnight sleep studies. This is a double-blind crossover study and subjects will take both pregabalin and a placebo.

RESPONSIVE NEUROSTIMULATION (RNS)

► Age 18-70; Has at least 3 disabling seizures per month; Has failed at least 2 AEDs           $25 per visit

Please contract Silvia (Room 734; 5-1936; sdone@neuro.columbia.edu).

■ Study participation is expected to last approximately 2 to 3 years with a study appointment every 1 to 3 months. Subjects will be implanted with the RNS device and seizure frequency and severity and physical and emotional health will be monitored throughout the study.

RUFINAMIDE

►Age 18-80; Has localization-related epilepsy; Has at least 3 seizures per month; Has failed at least 2 AEDs Transportation

Please contact Shefali (Room 734; 5-1617; ssharma@neuro.columbia.edu).

■ Subjects will keep a seizure diary and have phone interviews for an 8 week baseline phase. Subjects are then randomized to either rufinamide or a placebo which they take for about 14 weeks. There are 7 study appointments which include a physical exam and having blood drawn. Phone visits will be conducted between office visits.

Feel free to come to room 734 or call Alison Randall at 5-1684 to see if the appropriate research coordinator is available to speak with your patient while he/she is here for an appointment. Thank you.

UPCOMING EPILEPSY EVENTS IN NYC

Columbia Comprehensive Epilepsy Center – Pediatric Division
Epilepsy Awareness Morning Conference -
For Families, Friends and Caregivers of Children with Epilepsy-

We invite you to attend the Columbia Comprehensive Epilepsy Center’s Pediatric Epilepsy Awareness Morning conference held on Saturday, March 24th at the Columbia University Medical Center – New York Presbyterian Hospital. This conference will provide you with information about epilepsy in children and the many treatment possibilities that exist and the latest developments in newer treatments, research and the quality of life for children living with epilepsy.

Presentations will include information on new medications, surgery and alternatives therapies as well as how to improve epilepsy care and diagnostic methods for children. Speakers include Drs. Frank G Gilliam, Robert R Goodman, Cigdem Akman and Sudha Kessler.

For more information or to register for this free educational event (a continental breakfast at no cost),

contact: Francisco M. Rodriguez, Conference Coordinator at (212) 305-0457 or by email at fr2105@columbia.edu

Date:      Saturday March 24 th, 2007

Time:      9:00am to 1:00pm

Location: Winter Garden Conference Center

     3959 Broadway (166 th Street and Broadway)

     New York, NY 10032

OUR LADY OF MERCY EPILEPSY CENTER
& THE EPILEPSY INSTITUTE PRESENT A FREE
PATIENT AND CARETAKER EDUCATION PROGRAMS:

“EPILEPSY THROUGH THE LIFE SPAN”

WHEN: Saturday, May 19th 2007
TIME: Registration & Breakfast: 8:30 am
Educational Program: 9:00 am
WHERE: Richmond University Medical Center
355 Bard Avenue
Staten Island, NY 10301
MLB Conference Room
TO REGISTER: rbrett@epilepsyinstitute.org or call 212-677-8550 x 38

Sponsored by Richmond University Medical Center
& The Epilepsy Institute

OUR LADY OF MERCY EPILEPSY CENTER
& THE EPILEPSY INSTITUTE PRESENT A FREE
PATIENT AND CARETAKER EDUCATION PROGRAMS:

“EPILEPSY THROUGH THE LIFE SPAN”

WHEN: Saturday, June 23rd 2007
TIME: Registration & Breakfast: 8:30 am
Educational Program: 9:00 am
WHERE: Our Lady of Mercy Epilepsy Center
Conference Rooms A & B
600 East 233rd Street
Bronx, NY 10466
TO REGISTER: rbrett@epilepsyinstitute.org or call 212-677-8550 x 38

Sponsored by The Atlantic Neuroscience Institute at Overlook Hospital & The Epilepsy Foundation of New Jersey

THE SEIZURE DIAGNOSTIC CENTER
AT WHITE PLAINS HOSPITAL
& THE EPILEPSY INSTITUTE

PRESENT A FREE PATIENT AND CARETAKER EDUCATION PROGRAM

“EPILEPSY THROUGH THE LIFE SPAN”


WHEN: Saturday, September 8, 2007

WHERE: White Plains Hospital Auditorium
Davis Avenue at East Post Road
White Plains, NY 10601

TIME: Registration & Breakfast: 8:30 am
Educational Program: 9:00 am

TO REGISTER: rbrett@epilepsyinstitute.org or call 212-677-8550 x 38

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School Education Program
The Epilepsy Institute Public Education Division is targeting the New York City Schools to educate school nurses and all school staff about epilepsy, first aid, and supporting children with epilepsy in the classroom. If you are interested in having an in-service training at your child's school or learning more about the Public Education Division, call The Epilepsy Institute at 212-677-8550.

Ask the Nurse
The Epilepsy Institute is pleased to announce our new specialized Ask the Nurse program. Have you ever left a medical appointment with unasked or unanswered questions? If so you may wish to utilize our Ask the Nurse program. Do you have any questions regarding these or other medical issues?
- epilepsy prognosis
- nutritional counseling
- understanding medication side effects
- managing multiple medical conditions
- pregnancy and epilepsy
- treatment options

The Epilepsy Institute has a Clinical Nurse Specialist available to talk with you. Call The Epilepsy Institute at 212-677-8550 to arrange for an appointment.

Earned Income Tax Credit
Did you know that a family who has earned income up to $31,152 may be entitled to receive up to $3,888 refund through the Earned Income Tax Credit? This credit is a mechanism where the government provides cash assistance to working people. While in 1999, over 19 million families and individual workers received credits worth more then $30 billion estimates suggest that many workers who are eligible are not getting the credit. This is because they haven't heard about it, don't know that they are eligible or don't know how to apply.

This credit applies only to income earned through work, and is based on a person's modified adjusted gross income. Even if no tax is owed you may still qualify for this cash!

There are many factors that determine eligibility. The most important are income requirements. Families with two or more children can have income up to $31,152; families filing with one child can have income up to $27,413, and for single people the income limit is up to $10,380. For people who have a permanently disabled child living with them, the child can be any age. Otherwise a family may include children up to 19 years of age or, if the child is a full time student, up to age 24.

Every neighborhood in New York City has Volunteer Income Tax Assistance sites, which have been designated to help eligible people to apply for the Earned Income Credit and other credits. This service is free of charge.

If you are interested in learning more about the Earned Income Credit, the following resources may be helpful. IRS website - www.irs.ustreas.gov, IRS telephone assistance - 1-800-829-1040, Tele-tax - recorded tax information - 1-800-829-4477.

This information has been provided by The Epilepsy Institute. The Epilepsy Institute is dedicated to improving the lives of people with epilepsy and their families residing in New York City. For further information on The Institute's programs and services call 212-677-8550.

LATEST NEWS ABOUT EPILEPSY

The Epilepsy Coalition of New York State, Inc.

The Epilepsy Coalition of New York State, Inc. has been formed to promote awareness of epilepsy and its consequences to public and private sectors in New York State, and to provide more funding opportunities to the epilepsy service system throughout the state. The goal is to improve the quality of life for those who live with epilepsy on a daily basis. The Coalition's efforts have significantly expanded service opportunties and educational outreach throughout New York State. For more information about The Epilepsy Coalition of New York State, Inc. contact the number below.

The Epilepsy Coalition of NYS, Inc.
120 Washington Avenue
Albany, New York 12210
518/434-4360
518/434-4542 (fax)
Future website: http://www.epilepsyny.org.

Child Health Plus and Family Health Plus

• Did you know that ALL children in NY State have access to affordable health care?
  
• Child Health Plus is available free or low cost to all children not covered by Medicaid. If a family of four's annual income is less than $27,213, then all children qualify for FREE health care. For household income up to $37,852 the cost of health care is just $9 per month per child.
  
• Regardless of imigration status, all children are covered.
  
• Family Health Plus is a NEW program beginning in 2001, which will begin offering health insurance to singles and parents with low income but who do not qualify for Medicaid.
  
• Enrollment is being conducted by community based organizations. There is now just ONE form for the family to fill out for medicaid, child health plus, and family health plus. No running all over the city or waiting in long lines to enroll.
  
  If you are interested in finding out more about Child and Family Health Plus call 1-800-522-5006.

Vagus Nerve Stimulator

The Vagus Nerve Stimulator is the first new approach to treating epilepsy in over a 100 years! The FDA approved it in 1997 as an "add-on" therapy in reducing partial onset seizures that are not well controlled by medications for adults and adolescents over 12 years of age. It is now being used for many seizure types and in younger children.

The Vagus Nerve Stimulator is a pacemaker-type device, which is implanted under the skin on the chest. Thin wires run up to the neck where it stimulates the vagus nerve. The stimulator is programmed to give short pulses of electrical stimulation from the battery in the chest to the vagus nerve which then carries the energy to the brain. The clinician can alter the strength and frequency of stimulation non-invasively to adjust the "dose" to meet the needs of each individual patient. If the person with the implant or a family member senses that a seizure is likely to occur, they can pass a special magnet over the area in the chest where the generator is implanted to activate an extra, on-demand stimulation.

Although it is not fully understood how the Vagus Nerve Stimulator prevents seizures, some people's seizure frequency and intensity can be significantly reduced, though not usually eliminated
.
To find out more about the Vagus Nerve Stimulator contact the Epilepsy Institute at 212-677-8550, Cyberonics at 1-800-332-1375, and/or talk to your doctor to find out whether this treatment is right for you.

New Medication

Keppra On June 24, 2005, UCB Pharma announced that the U.S. Food and Drug Administration approved the company's antiepilepsy medication, Keppra (levetiracetam) as an add-on treatment of partial-onset seizures for children with epilepsy who are four years of age and older. This approval for children was based on a six month priority review. Keppra was approved in 1999 as an adjunctive therapy for adults with partial onset seizures.

Lyrica (pregabalin) On June 13, 2005 Pfizer announced that it received FDA approval to market Lyrica as an add-on treatment for partial onset seizures in adults with epilepsy. Lyrica has already been approved for treating epilepsy patients in 46 countries. It will be available in US pharmacies in the fall of 2005.

Trileptal (oxcarbazepine) was recently approved as an add on therapy of partial and complex seizures for adults and children over four years of age. Trileptal is usually taken two times a day.

Keppra (levetiracetam) was approved as an add-on medication for treatment of partial and complex seizures. Because Keppra is not chemically related to other anti-seizure medications, it does not interfere with how the body metabolizes other anti-seizure medications. Keppra is usually taken two times a day.

Zonegran (zonisamide), which is chemically unlike other AEDs, was approved by the FDA as add-on therapy for partial seizures in persons age 16 and above. It has been used in Japan and other countries for over ten years.

Topamax (topiramate) is an antiepileptic drug used for adjunctive therapy for adults and ediatric patients above the age of 2 years with partial onset seizures or primary generalized tonic-clonic seizures. In October 1998, a sprinkly formulation of Topamax was approved by the FDA. With this new formulation the capsule can be opened and its contents can be sprinkled onto soft food for easier swallowing, or the capsule can be swalloed whole, offering patients greater flexibiity.

Gabitril (tiagabine hydrochlorine) is an antiepileptic medication used for adjunctive therapy for adults and children 12 years and older in the treatment of partial seizures.

Lamictal (lamotrigine) is an antiepileptic medicatin indicated for monotherapy and adjunctive therapy in adults with partial seizures, and as adjunctive therapy in the generalized seizures of Lennox-Gastaut syndrome. Felbamate is an add on therapy or a single drug therapy.

Diastat (diazepam rectal gel) is a gel formulation of diazepam used for select patients with epilepsy, who take AEDs regularly, but require use of diazepam to control bouts of increased seizure activity or clusters of seizures quickly. This is a new rectal gel formulation of diazepam, also known as valium, which is also prescribed in a pill or given as an injection.