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Testing of a Modified Antiepileptic Drug in Healthy Volunteers Completed

Thu, 01/19/2017 - 05:00

Adamas, a pharmaceutical company based in California, has announced the completion of a Phase1 clinical trial testing the drug candidate ADS-4101 for the treatment of partial onset seizures.

ADS-4101 is a new version of the existing antiepileptic drug (AED) lacosamide (Vimpat®) that is already approved by the US Food and Drug Administration (FDA) and the European Medicine Agency (EMA). However ADS-4101 is designed to be taken once a day unlike Vimpat, which is usually taken twice a day. It is specially manufactured in an effort to improve seizure control when it is most needed and limit side effects at other times.

“With our confirmed understanding that epileptic seizures primarily occur during the day, we are developing ADS-4101 to deliver high concentrations of medicine during the day when seizures occur,” said Dr Gregory Went, the chairman and chief executive officer of Adamas Pharmaceuticals, in a press release. “We believe ADS-4101’s promising profile may potentially provide a clinically meaningful benefit to patients with epilepsy.”

The trial compared the safety, tolerability, and properties of four different versions of ADS-4101 in 24 healthy volunteers and compared them with lacosamide. According to the company, the best version will then be tested in further clinical trials. “We are encouraged by the results of this Phase 1 clinical trial in ADS-4101 and look forward to advancing the program in 2017,” Went said.

Dr Graeme Sills, chairman of the Board of Trustees of Epilepsy Research UK and Senior Lecturer in Pharmacology at the University of Liverpool, suggested that this report should be considered cautiously. “This is a very interesting concept but much more research is required before we can assess whether it will deliver genuine benefits for people with epilepsy whose seizures are not adequately controlled by existing drugs” he said.

Please note that Epilepsy Research UK does not endorse/promote individual epilepsy treatments or pharmaceutical companies.

Author: Dr Özge Özkaya

Click here for more articles about anti-epileptic drugs and pregnancy risks.




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Get active for research!

Wed, 01/18/2017 - 11:37

This year  once again brings a fantastic events calendar with lots of exciting sporting events and challenges to get involved in! Proudly wear your green ERUK colours and make 2017 our best year yet!

Join Team ERUK
No matter what your ability there is something for everyone.  Whether a 5K Fun Run, Sponsored Walk, Marathon or Cycle event there is loads to choose from, in all locations around the UK. If you’re feeling particularly brave why not sign up for a Parachute Jump too!  Details of all the events we have places in can be found in our Event Pages.

Already have your own place?  If you have your own place we would love you to join our team!  There is no minimum sponsorship for own place runners, just email Jo to let us know you have your place and receive your fundraising pack.

Not able to run? How about volunteering to join our cheering squad for Team ERUK and help them reach the finish line! Contact Jo on 020 8747 5024  or jo@eruk.org.uk for details.

Every pound raised will help us to increase the amount of research we can fund and we really hope to have the biggest running team we’ve ever had out in force throughout 2017!

Jo Finnerty, Events Fundraiser says, “2016 brought some fantastic fundraisers, with Epilepsy Research UK being the Official Charity for the British 10K in July a particular highlight.  Everyone who took part last year went to great lengths to raise awareness for epilepsy and madesponsorship to help boost the research that we can fund. It was a fantastic year!!  I’m really looking forward to 2017  and supporting all those who are out flying the flag for Team ERUK. Each and every one of whom is helping us transform the lives of people with epilepsy and we’re so grateful for their support.”

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Common and Rare Epilepsies Share Genetic Mutations

Wed, 01/18/2017 - 08:02

Several genes previously thought to be associated with only rare types of epilepsy seen in children are also involved in more common types of the condition, according to a study published in the scientific journal The Lancet Neurology.

This finding suggests that therapeutic approaches, which target the precise genetic cause of epilepsy and which are used to tackle rare forms of the condition may also be helpful in treating its more common forms.

“This is a very exciting breakthrough in the treatment of epilepsy, in which current treatment is based on whether a child has focal seizures, which begin in one area of the brain, or generalized seizures,” said Dr James Riviello, Chief of Child Neurology at Columbia University, New York, in a press release. “Genetic testing for epilepsy may allow us to identify the specific anticonvulsant medication that potentially works best for an individual patient. We have already identified children in whom knowing the underlying genetic basis of the epilepsy has guided our treatment choices.”

The study involved the comparison of all protein coding genes from 1,140 people with one of two common types of epilepsy – genetic generalised epilepsy and non-acquired focal epilepsy – with those from 3,877 people without epilepsy.

The researchers found that some people with non-acquired focal epilepsy had significantly more mutations in five specific genes that were previously thought to be associated with rare forms of the condition only. They estimated that these five genes contribute to epilepsy risk in approximately eight percent of people with this common form of the condition. A similar pattern was observed for genetic generalised epilepsy.

According to the authors, as more genes associated with a wide range of epilepsies are identified, more treatments that are targeted to an individual’s genetic subtype can be developed. In the future, with more samples being analysed, the researchers are hoping to find additional genetic variations that contribute to common epilepsies.

The research was coordinated by the Epi4K collaboration, an international consortium of doctors and scientists from around the world. The study was funded in part by Epilepsy Research UK and several UK researchers were involved, including Prof Mark Rees and Dr Graeme Sills, who are both trustees of Epilepsy Research UK.

Author: Dr Özge Özkaya

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People with Drug Resistant Nonlesional Neocortical Epilepsy Could Benefit from Brain Surgery

Tue, 01/10/2017 - 08:14

People with nonlesional neocortical epilepsy could benefit from brain surgery and become seizure-free in the long term according to a study published in the scientific journal JAMA Neurology.

Dr Dong Wook Kim and colleagues explored factors that might help select people with nonlesional neocortical epilepsy who are most likely to benefit from surgery. The researchers analysed data from 109 people, aged seven to 56,with drug resistant neocortical epilepsy (which arises from the surface of the brain), and who attended Seoul National University Hospital in South Korea between 1995 and 2005.

All of the patients had failed to respond to treatment with at least two antiepileptic drugs (AEDs) but none had abnormalities or lesions in the brain identifiable by MRI (hence “nonlesional”). Nevertheless, all of the patients underwent surgery to remove the part of the brain that their doctors believed to be responsible for their seizures.

One year after surgery, 59 of the 109 patients (54%) were completely free from seizures and a further 37 patients (34%)had notable reductions in seizure frequencybut without achieving complete remission.

All of the patients, except one, were then followed up clinically for at least 10 years, and some for as long as 21 years after surgery. A total of 64 patients (59.3%) were seizure-free and 33 patients (30.6%) had a lower seizure frequency at their last clinical follow-up, suggesting that the effectiveness of surgery was maintained in the longer-term.

Although the chance of achieving seizure freedom was lower than would be expected for people with mesial temporal lobe epilepsy or lesional neocortical epilepsy, according to the authors “it was notable that nearly 90% of patients benefited from resection surgery for nonlesional neocortical epilepsy.”

People with nonlesional neocortical epilepsy are not usually considered optimal candidates for surgery, but recent studies have shown that a greater proportion of people with this type of epilepsy are being offered surgical intervention. This study supports the benefits of surgery in those patients but further research is needed to confirm the results presented here.

Author: Dr Özge Özkaya

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Nasal Spray to Treat Cluster Seizures Gets Fast-Track Designation from the FDA

Tue, 01/10/2017 - 08:06

The pharmaceutical company Neurelis Inc. recently announced that the US Food and Drug Administration (FDA) has granted fast-track designation for NRL-1, a special formulation of diazepam, for the treatment of epilepsies that are characterised by clusters of seizures. This means that the new formulation could become available more quickly.

“We are very excited to have received Fast Track Designation status with the FDA,” said Craig Chambliss, President and Chief Executive Officer of Neurelis, in a press release.  “We are looking forward to working with the FDA as we complete our clinical development work….. and prepare for the commercialization of NRL-1.  We are focused on providing epilepsy patients and health care providers with an effective, well-tolerated, and user-friendly product for the treatment of acute repetitive or cluster seizures.”

Diazepam is a drug used to treat anxiety, alcohol withdrawal, muscle spasms, and some types of seizures. NRL-1 is a diazepam nasal spray, which is being developed for the treatment of children and adults with epilepsy who require recurrent use of the drug to control bouts of acute repetitive seizure activity, also known as cluster seizures.

Previous clinical studies have shown that NRL-1 is generally safe and well tolerated and that there is little variability from dose to dose. The new formulation is in its final stage of clinical testing, after which the company will submit a New Drug Application (NDA) to the FDA requesting marketing authorisation for NLR-1. The company says that they plan to market NRL-1 worldwide.

For many years, the only treatment option for people with cluster seizures was to administer diazepam rectally, which was challenging under some circumstances. That changed with licensing of buccal midazolam in the UK in 2011. It is hoped that NRL-1 will offer a further treatment option for people with cluster seizures and allow the delivery of a therapeutic dose of diazepamvia a nasal spray rapidly and easily in many settings.

Please note that Epilepsy Research UK does not endorse/promote individual epilepsy treatments or pharmaceutical companies.

Author: Dr Özge Özkaya

Click here for more articles about anti-epileptic drugs and pregnancy risks.

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ADHD Drug Could Improve Brain Function in People with Epilepsy

Thu, 01/05/2017 - 11:02

Methylphenidate (MPH), a drug used for the treatment of attention deficit and hyperactivity disorder (ADHD), could improve cognitive problems in people with epilepsy, according to a study published in the scientific journal Neurology.

This suggestion is based on the results of a clinical trial that included 35 adults with epilepsy aged between 20 and 62 years, who had long-standing cognitive complaints, including poor attention and memory. The trial compared the effect of MPH, given in divided doses one week apart, with an identical looking dummy pill. Neither the participants nor the doctors knew who was getting the drug and who was getting the dummy until the trial had ended.

A total of 31 participants completed the trial, of whom 24 had focal epilepsy, six had generalised epilepsy and one had unclassified epilepsy. The average duration of epilepsy among the participants was 12.5 years with an average frequency of 2.8 seizures per month.

The research was led by Dr Kimford Meador, from Stanford University Medical Center in California, and evaluated cognitive function using three different tests. These were the Medical College of Georgia Paragraph Memory Test, the Conners Continuous Performance Test, which assesses attention and vigilance, and the Symbol-Digit Modalities Test, which measures general brain dysfunction. Seizure frequency and adverse effects of MPH were also monitored.

Overall, MPH treatment resulted in a significant improvement in cognitive performance. No change in seizure frequency was observed in any of the participants and only three people withdrew from the trial due to adverse effects. These included “fogginess” in thinking ability, anxiety and agitation, and tachycardia (fast heart rate while at rest).

The authors concluded that MPH may be effective in improving cognitive deficits in people with epilepsy, but they advised that additional studies are needed to confirm this finding.

Author: Dr Özge Özkaya

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Gene Associated with Bipolar Disorder also Linked to Epilepsy

Thu, 01/05/2017 - 05:36

A gene called ANK3, which is associated with bipolar disorder (formerly known as manic depression) could also be linked to epilepsy, according to a study published in the scientific journal Molecular Psychology.

This new finding means that ANK3 could be targeted and opens new potential avenues for the treatment of epilepsy.

Research led by Dr Edward Cooper, at Baylor College of Medicine in Houston, Texas, has shown that reduced expression of one variant of the ANK3 gene causes an imbalance between nerve cell excitation and inhibition.

The team found that a protein encoded by a variant of the ANK3 gene, which is reduced in people with bipolar disorder, is selectively lost from inhibitory neurons, or neurons that block firing, meaning that the excitation/inhibition balance is shifted towards excessive excitation.

In a press release from Baylor, Dr Cooper said: “We found that reduced expression of one type of ANK3 removes a brake on the output of brain neurons, leading to excesses in firing in circuits for emotions, memory and epilepsy”.

In order to test the effect of this imbalance, researchers created a mouse model lacking the inhibitory form of the ANK3 gene. They found that the animals had frequent epileptic seizures and a high risk of sudden death.

“This showed us that imbalance in ANK3 function can result not only in excessive circuit sensitivity and output leading to bipolar disorder, but also severe epilepsy,” Dr Cooper said.

Dr Cooper and his team discovered, around ten years ago, that ANK3 interacts with two other genes that are mutated in some people with epilepsy. Soon after, genetic testing on a large number of psychiatric patients across the world revealed that ANK3 is linked to bipolar disorder but the connection with epilepsy remained unclear. Through this work the connection between ANK3 and epilepsy has been unravelled for the first time.

Author: Dr Özge Özkaya

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Continuous EEG Recording Could Help Doctors Identify People Most at Risk of Developing Seizures

Tue, 01/03/2017 - 09:02

Continuous electroencephalographic (EEG) monitoring and a detailed interpretation of the data obtained from such monitoring could help doctors classify patients according to their risk of having seizures, according to a study published in the medical journal JAMA Neurology. This knowledge could help them make better clinical decisions such as treating those at higher risk of seizures with more aggressive treatment approaches.

In order to identify the specific characteristics of periodic and rhythmic EEG patterns they may be associated with an increased risk of seizures, Dr Andres Rodriguez Ruiz, of Emory University School of Medicine, and colleagues, reviewed EEG recordings from 4772 critically ill adults. The recordings were taken at Brigham and Women’s Hospital, Yale University Hospital, and Emory University Hospital between February 2013 and September 2015 and corresponded to 5742 sessions averaging 12 hours each. Epileptic seizures occurred during 719 sessions and in 530 of these (74%) periodic/rhythmic patterns were also recorded. 

The researchers analysed the EEGs in detail looking for different patterns of electrical activity called lateralized periodic discharges (LPDs), lateralized rhythmic delta activity (LRDA), generalized periodic discharges (GPDs), bilateral periodic independent discharges (BIPDs), and generalized rhythmic delta activity (GRDA).

The results showed that more LPDs and GPDs were associated with an increased risk of developing seizures. LPDs had the highest association with seizures regardless of their frequency, while LRDAs and GPDs were associated with seizures in a frequency-dependent manner. Finally, the researchers found that patients who had GRDA patterns were not any more likely to have seizures than those with no rhythmic/periodic patterns of activity recorded on the EEG.

According to the authors, “These findings highlight the importance of detailed electroencephalographic interpretation” to group patients according to their risk of developing seizures “and clinical decision making”. They also point to the importance of using a standardized terminology to describe the specific patterns recorded during the EEG.

Continuous EEG monitoring is a powerful technique, which is increasingly being used to monitor brain activity in order to clearly diagnose and detect non-convulsive epileptic seizures with great sensitivity.

Author: Dr Özge Özkaya

Click here for more articles about brain science including genetics.

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