Vall d'Hebron University Hospital Epilepsy Unit, an international leader in clinical trials

The Epilepsy Unit of Vall d'Hebron University Hospital has participated in recent years in the major drug clinical trials for the treatment of the disease and it is internationally leading patient recruitment. In this regard, the Unit has been the number one worldwide in the inclusion of patients (34) of the trial that allowed the release of the new drug Briviact (Brivaracetam). It is a drug indicated as adjunctive therapy (added to other therapy) of partial onset seizures -in a part of the body- in adults and adolescents over 16 years old. In addition, during the phase of approval by regulatory agencies, the Epilepsy Unit was audited by the trial sponsor and inspected by the FDA (the US health authority), which confirmed that the monitoring of patients met all the requirements of the protocol and Good Clinical Practice.

In parallel, it has been just authorized the use of Vimpat (Lacosamide) as monotherapy in patients with focal epilepsy, in which the Epilepsy Unit again led the inclusion of patients (28) in an international and multicentric clinical trial, which has followed up for five years those patients randomly assigned to the Lacosamide group.

The Epilepsy Unit is a multidisciplinary team of professionals in neurology, neurophysiology, radiology, paediatric neurology, nursing, statistics and neuropsychology who help to have a more comprehensive view of the epileptic patient.

Dr. Manuel Toledo, member of the Epilepsy Unit of the Vall d'Hebron University Hospital and researcher at the Vall d'Hebron Research Institute (VHIR), explains that "we plan to continue participating in clinical trials with the aim to provide the patient with epilepsy the best treatment available, especially those resistant to medication and patients whose seizures are not controlled with current treatments."

The Epilepsy Unit has also led two phases II and III clinical trials with cannabis derivatives for adult patients with drug-resistant focal epilepsy.

Epilepsy

Epilepsy is a chronic brain disease that affects people around the world and is characterized by recurrent seizures that are caused by excessive electrical discharges of groups of brain cells. These seizures are brief episodes of involuntary movements that can affect a body part (partial seizures) or whole (generalized seizures) and sometimes accompanied by loss of consciousness and sphincter control. Its frequency can vary from one or less a year to several per day.

Epilepsy is a disease that affects the entire population, regardless of age, from before birth to people over 90 years old. It is estimated that its prevalence is 8 per 1,000 people. Epilepsy is the second neurological disease -after ictus- most treated in the emergency room. At a care level, around 3,000 patients visit the Hospital each year. It is also estimated that 3% of the population will have to go sometime in their life to hospital to rule out that the symptoms they are suffering are not from epilepsy.

Acute Phase

The Epilepsy Unit at the European level is a benchmark in recruitment of patients in a multicentre trial of acute phase for patients with super-refractory epilepticus status. This is a clinical trial, whose Principal Investigator is Dr. Estevo Santamarina, offering a therapeutic alternative for patients who do not respond to the first, second or third line drug treatment currently available to treat them. An epilepticus status is a condition of crisis and repetitive discharges (one or more) that can last for about 30 minutes without recovery of consciousness, despite the first-line treatment. When the second line fails, it is considered a refractory epilepticus status, and if the third line fails, it is a super-refractory epilepticus status. The status can cause significant brain damage including brain death, neuronal damage and impaired neural networks, depending on the cause and duration. It is estimated that more than 50 patients a year with status are assisted at the Hospital for treatment.