Marinus Pharmaceuticals Inc, a pharmaceutical company dedicated to the development of innovative therapeutics to treat seizure disorders, is initiating the RESET (Researching Established Status Epilepticus Treatment) study, which is being conducted in the emergency department at approximately 50 hospitals across the US. The purpose of the RESET study is to determine the safety and effectiveness of ganaxolone (an investigational medicine) when administered in addition to current medicines used to treat prolonged seizures. Investigational means ganaxolone has not been approved by the US Food and Drug Administration for use outside of clinical studies like this one and it is important to evaluate if a disease or medical condition improves while taking it as part of the clinical study.
When a patient arrives at a hospital’s emergency department experiencing prolonged seizures or SE, the standard practice is to administer a benzodiazepine (first-line treatment) followed by an IV antiepileptic drug (second-line treatment). If the seizures have not stopped after the first- and second-line treatment have been given, the patient then moves into the third stage of SE, also known as refractory status epilepticus (RSE). Because current medicines used to treat ESE have been shown to be ineffective in over 50% of patients, the RESET study is trying to evaluate if adding ganaxolone to the second-line treatment (an IV antiepileptic drug) would improve seizure control in more patients.
To be eligible for the RESET study, a patient must still be having seizures after the first-line treatment has been given, which is typically a benzodiazepine such as diazepam. Once enrolled in the study during this open label phase, or phase 1, the doctor will give the patient one of the common antiepileptic drugs and also add ganaxolone in an effort to stop the seizures.
This is an Exception from Informed Consent (EFIC) study that will be performed in the emergency departments, which means that anyone 18 years or older who continues to seize despite the first-line seizure treatment, a benzodiazepine, could potentially participate in the study. The first-line treatment may be administered prior to arriving at the emergency department and those patients would still be eligible to participate.
Everyone in this study will receive medicine for their seizures. The clinical study has two parts. During the first part, everyone will receive the standard first- and second-line treatment medicines and IV ganaxolone. The first part of this study will involve no more than 40 patients to find the best dose of ganaxolone to be used in part 2 of the study.
Once the first part of the study has finished, the second part of the study will start and will involve approximately 80 patients. In the second part of the study, everyone will still get the standard treatment medicines (including a benzodiazepine and an antiepileptic drug). All patients receive standard medicine and will be randomly assigned to receive either ganaxolone or placebo (no medicine) in addition to the standard medicine. Random means assigned by chance, like the flip of a coin. One out of two patients will receive ganaxolone while the other will receive placebo and the standard of care. A placebo looks like ganaxolone but does not contain any active medicine. Study doctors use a placebo to see if ganaxolone is more effective than not taking the investigational medicine at all.
Whether a patient receives ganaxolone or placebo, in combination with the standard second-line treatment medicine, the study doctor will continue to evaluate the patient’s progress and monitor the patient for any potential side effects for 4 weeks.
Those who choose not to participate in the RESET study can request an “opt-out bracelet” to be worn while the study is enrolling. The opt-out bracelet is a wrist band; “the RESET study” and “Marinus” appear on one side and “Opt-Out” appears on the opposite side. The opt-out bracelet is a way for a person to indicate their desire to not participate in the RESET study.
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