A clinical study is happening across the U.S. to explore an investigational treatment option for patients who experience prolonged life-threatening seizures. Status epilepticus (SE) is the most severe form of epilepsy and is a neurological emergency that requires urgent treatment to avoid possible permanent brain damage, death or other lasting problems. The diagnosis of SE is considered when someone has a seizure for longer than five minutes OR has two or more seizures occurring within a five-minute time span without returning to a normal level of consciousness between the seizures.
Based on a variety of factors such as cause, age, and duration of the seizure, approximately 3% – 26% of patients with SE do not survive. Since longer seizures lead to greater risk of injury and death, it is important to treat patients experiencing SE as quickly as possible to try to stop the seizures. This study will be performed in the emergency department and anyone 18 years or older who continues to seize despite the first-line seizure treatment, a benzodiazepine, could potentially be eligible to participate in the study.
Due to their seizure condition, the patients in this study may be unconscious and unable to consent for themselves. Because the patient is experiencing a neurological emergency that requires urgent treatment, there is a small window of time to give that patient the study medication that may potentially help them. Under these circumstances, this clinical study may enroll patients without their consent under special FDA regulations that are permitted for emergency research, otherwise known as Exception from Informed Consent (or EFIC).
Those who choose not to participate in the RESET study can request an “opt-out bracelet” to be worn while the study is enrolling with “the RESET study” and “Marinus” on one side and “Opt-Out” 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.
To learn more information about the RESET study, EFIC, or request an opt-out bracelet, please visit our website (TheRESETStudy.com). Additionally, if you have any questions, comments or concerns about this study, you may participate in an online survey or focus group to provide your feedback. Space is limited for the focus group and a $50 gift card will be provided for your participation.