Efficacy and Safety of Perampanel in the Treatment of Refractory Status Epilepticus

• Status: Not yet recruiting
• Trial end date: 2028-01-04
• Target enrollment: 0
• Participant gender: All

Summary

This project is aiming to better understand the use of perampanel as an appropriate standard-of-care therapy for treatment refractory status epilepticus (RSE), to identify determinants of outcomes, and establish safety. The study will recruit 25 patients at WSU. The study will last for about 96 weeks and will involve a screening visit and two in clinic visits at 3 and 6 months. If the subjects give written informed consent and meet all eligibility criteria they will be clinically evaluated and will be given the study drug. This study will involve recording of patients medical history, drug history and epilepsy history. A physical exam and a and neurological exam will also be performed to study the heath status of the participant. Results and patient information will be stored in a database for analysis to find commonality among key factors that have been seen in past research.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wayne State University

Criteria

Inclusion Criteria:

• Adults patients equal or greater than 18 years

• Patients in RSE that require IV anesthetic infusions. Note: RSE is defined as status epilepticus that fails to terminate after an adequate dose of benzodiazepines (1st line agents) and an AED (2nd line agent). Adequate doses have been defined in the screening (below).

• Patients taking oral contraception who will be on the study long term should be informed about additional alternative methods of contraception.

Exclusion Criteria:

• Childbearing potential female who has a positive pregnancy test result or is otherwise known to be pregnant. Hypoglycemia or hyperglycemia induced seizures

• Mild, moderate or severe hepatic impairment

• Severe renal impairment or on hemodialysis

• History of psychiatric illness or suicidal behavior/ideation

• Previous or current use of PMP

• Known severe allergy to any AED

• Anoxic brain injury as etiology of status epilepticus

• Use caution in patients taking moderate and strong CYP3A4 Inducers (including carbamazepine, oxcarbazepine, and phenytoin)

• Patients on other forms of strong CYP3A4 (e.g. Rifampin, St John's Wart, etc).