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Not Yet Recruiting NCT05684978

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

Conditions: Refractory Status Epilepticus

Sex: All
Ages: 18 Years – 100 Years
Phase: PHASE4
Enrollment: 25
Sponsor: Wayne State University

Location: United States

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.

Eligibility Criteria

Inclusion Criteria:Adults patients equal or greater than 18 yearsPatients 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 seizuresMild, moderate or severe hepatic impairmentSevere renal impairment or on hemodialysisHistory of psychiatric illness or suicidal behavior/ideationPrevious or current use of PMPKnown severe allergy to any AEDAnoxic brain injury as etiology of status epilepticusUse 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).

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05684978). StuddyBuddy aggregates publicly available trial information.