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

Launched by WAYNE STATE UNIVERSITY · Jan 6, 2023

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ClinConnect Summary

This clinical trial is looking at a medication called perampanel to see if it can help patients with refractory status epilepticus (RSE), which is a serious condition where seizures don’t stop even after receiving standard treatments. The goal is to determine how effective and safe perampanel is for these patients. The trial will involve 25 participants at Wayne State University and will last about 96 weeks. Eligible individuals are adults aged 18 and older who are experiencing RSE and need intravenous (IV) medications to manage their seizures.

If you or a loved one qualifies, you will go through an initial screening and then have two follow-up visits at 3 and 6 months. During these visits, your medical history will be reviewed, and you will undergo physical and neurological exams to assess your health. Participants will receive the study medication, and information will be collected to help researchers understand more about the treatment's effectiveness and safety. It’s important to know that certain individuals, like those with specific medical conditions or who are pregnant, may not be eligible to participate.

Gender

ALL

Eligibility 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).