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Neurological Disorders

Experts Discuss the Need for More Epilepsy Research

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Manisha Holmes, MD

Assistant professor of Neurology, NYU Langone’s Comprehensive Epilepsy Center

Are there risks associated with epileptic women carrying a baby?

There are risks; Seizures can be extremely dangerous to both mother and baby by potentially resulting in injury, miscarriage, low-birth weight, preterm labor. Anti-seizure medications can also pose a risk to the baby, with 4-6 percent of women on anti-seizure medications giving birth to a baby with major congenital malformations (MCM) versus this occurring in only 2 percent of the general population. Women with good seizure control prior to pregnancy will likely continue to be well-controlled, however. Discussing plans for pregnancy early with an epileptologist can help minimize risks by optimizing seizure control with the safest medication and dosing possible.

Can epilepsy cause complications during delivery?

In 2015 a retrospective review by MacDonald et al. was published looking at a representative sample of 20 percent of U.S. hospitals. The review suggests, though still rare, that there is an increased risk of death, preeclampsia, preterm labor, stillbirth and need for cesarean section in women with epilepsy compared to those without the condition. Keep in mind, however, that this study did not account for variance in seizure control, use of anti-seizure medications or co-morbid conditions. Coordination of care between obstetricians and neurologists may also help to mitigate these risks.

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Volker Knappertz, M.D.

Chief Medical Officer, GW Pharmaceuticals PLC

Is there a need for more research?

There is an urgent need for more research both into the mechanisms by which these brain conditions decrease the seizure threshold and on the long-term outcomes of treatment and treatment regimens as well as in defining the joint effects of anti-epileptic drugs and into the development of novel treatments with improved benefit to risk profiles. Greenwich Biosciences, Inc.is committed to developing medicines for these conditions and to contributing to all aspects of the required research activities in close collaborations with the research and patient communities.

What are the greatest challenges to this kind of work?  

Conducting clinical trials with DEA-scheduled substances such as cannabinoids certainly add complications and require significant commitment from both the sponsor developing such medicines as well as the clinical researchers involved.

Clinical patient trials also pose several challenges to patients and their families — knowing that a child entering a controlled trial may receive a placebo added onto their current treatment and medication regimen, even if only for a limited time, may be difficult for the caregivers. It requires a good dose of altruism to be motivated to participate in such controlled research, knowing that the results will further our understanding of the test substance and will enable the researchers to advance such experimental medicines into licensed products that will hopefully benefit many in the future. These trials do require additional clinic visits, various tests, blood draws and other commitments, however, so we need to balance the desire to find a treatment that works as quickly as possible for the individual while taking the patient and caregiver positions into account when designing the protocols for such trials.

Why are clinical trials so important?  

Clinical trials are our key research tool for advancing medical knowledge, broad patient care and for moving from initial signals — and, at times, anecdotal reports of efficacy, tolerability and safety — of new medicines to evidenced-based medicine. Randomized, double-blind placebo-controlled trials have been the gold standard for drug development and subsequent regulatory approval.

The clinical data that results from these trials provides physicians with an understanding of the new drug’s efficacy and safety profile, the appropriate dosing and other important information (such as how the new drug potentially interacts with other medications that the patient may be taking.) Recently, different clinical trial approaches — including active comparators, the use of sensors and technology as well as shorter trial periods — have been advocated and are being assessed. Greenwich Biosciences, Inc. is committed to working closely with clinical trialists and regulators to use the most patient-centric approaches appropriate for drug development.

When are new, innovative therapies and medications a needed treatment option? 

Rare diseases place a tremendous burden on patients and their loved ones, in part because they are often difficult to treat or have no systematically-studied treatments at all. Consequently, there is a high and unmet medical need for new treatments, assessments of effectiveness and safety in these rare conditions.  The FDA has defined a process by which new medicines can be evaluated to address the needs of these patients. While the FDA’s process may appear complex, it is designed to protect the individual patient in the studies and, when successfully completed, will result in a regulatory dossier of the new medicine’s safety and efficacy based upon well-controlled clinical and preclinical evaluation. This data is the foundation for patients and healthcare providers to have confidence in a new medicine and use these treatments with a thorough understanding.

In your opinion, what developments in the field show the most promise?

Research is being conducted for new categories of drugs that have not previously been evaluated for the treatment of epilepsy and, more specifically, rare neurodevelopmental disorders that go along with epilepsy such as Dravet syndrome, Lennox-Gastaut syndrome and tuberous sclerosis complex. Should these drugs be approved by the FDA, they could provide treatment options for thousands of patients and their families who continue to live with the daily challenges of uncontrolled seizures, undesirable side effects associated with currently approved antiepileptic drugs and a reduced quality of life.

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Twyila Lay, RN, MS, ACNP

President, American Association of Neurological Nurses

What sets neurological nurses apart from other registered nurses?

Our advanced knowledge of the brain and spinal cord as well as our expert assessment skills allow neuroscience nurses to promptly identify subtle neurological changes that may otherwise go unrecognized. This ability to rapidly localize the site of injury enhances communication and early intervention, preventing the development of secondary injury.  

What is the most important aspect of a neurological nurse’s job?

In addition to the above, the most important aspect of our job is mentorship. Mentorship fosters diversity. Mentoring helps to develop future leaders who will further influence and advance the science of neurological nursing.

What is one piece of advice that you would give someone considering entering this line of work? 

I’d recommend joining a professional association. They are invaluable, made up of individuals who have similar interests, passions and dedication. When you look at the statistics of our association, over 80 percent of our membership have a minimum of a Bachelor’s degree and over 30 percent have an advanced degree of either Masters or PhD. The majority have additional advanced certification as well, allowing them to practice to the full extent of their education and training. You won’t find a better way to learn, grow and develop than being part of such a diverse group of professionals.

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Dr. Eli Mizrahi, MD

President, American Epilepsy Society

Unfortunately, epilepsy often carries stigma with it — how can this affect individuals with epilepsy coming to terms with their diagnosis?

We have made some progress in overcoming the social stigma associated with epilepsy, but it is still very real for many; Stigma may even deter some from seeking medical care or make them less willing to share the nature of their condition with others who may be able to help if seizures occur. We want people with epilepsy to understand the importance of seeking specialized care because treatments and holistic care can help them control their seizures and address quality of life issues.

What are some ways that individuals can overcome this stigma and find pride in their epilepsy?

It is important for individuals with epilepsy to accept their diagnosis and take responsibility for managing the new needs they will have as a consequence of having the disorder. This management would be in partnership with the individual’s healthcare team and the support of family and friends. The goals should include adhering to medication schedules, eating and sleep well as well as doing personal research into epilepsy treatment and management options. This research will help those with epilepsy to handle stigma by being prepared to talk about the condition accurately and explain the positive ways you can manage your life with epilepsy; Above all be realistic about it and know your own epilepsy needs.

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