Early Administration of Perampanel for Seizure Recurrence Prevention After Status Epilepticus

JRCT ID: jRCT1031240531

Registered date:09/12/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Convulsive status epilepticus
• Date of first enrollment: 09/12/2024
• Target sample size: 60
• Study type: Interventional
• Intervention(s): Intravenous administration of 2mg perampanel after cessation of convulsive status epilepticus

Outcome(s)

• Primary Outcome: Seizure recurrence rate within 24 hours after perampanel administration following the cessation of status epilepticus

Secondary Outcome

1.Rate of endotracheal intubation within 24 hours
2.Rate of third-line treatment implementation within 24 hours. (Third line treatment as per Epilepsy Treatment Guidelines 2018 General anesthesia using midazolam, propofol, or barbiturates)
3.Seizure recurrence rate within 7 days
4.Rate of endotracheal intubation within 7 days
5.Rate of third-line treatment implementation within 7 days
6.Median modified Rankin Scale (mRS) score on day 7
7.Transition rate from intravenous antiepileptic drugs to oral formulations of the same medication
(FPHT IV to oral phenytoin, LEV IV to oral LEV, PER IV to oral PER)
8.Duration of perampanel intravenous administration
9.Total perampanel dose administered by day 7
10.Rate of EEG implementation within 24 hours
11.Rate of EEG abnormality detection within 24 hours
12.Rate of EEG implementation within 7 days
13.Rate of EEG abnormality detection within 7 days
(EEG abnormalities include spikes, spike-and-wave complexes, sharp waves, periodic discharges, rhythmic delta activity, and other epileptiform abnormalities)
14.Serious adverse events (cardiac arrest, lethal arrhythmias such as ventricular fibrillation, respiratory arrest, hypotension, etc.)
15.New onset psychiatric symptoms (aggression, irritability, suicidal ideation, etc.)

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Patients with convulsive status epilepticus
2. Patients transported by emergency services or those with in-hospital onset
3. Administration of benzodiazepines as the first-line treatment
4. Administration of either LEV (Levetiracetam) or FPHT (Fosphenytoin) as the second-line treatment
5. Cases where the principal investigator or co-investigator has determined that the seizures have ceased

Exclude criteria

1. Patients under 18 years of age
2. Patients who have previously participated in clinical studies involving status epilepticus
3. Patients who are already intubated before the start of treatment
4. Patients with known allergies to the study drug perampanel
5. Patients who have a history of oral administration or intravenous infusion of perampanel within the past month
6. Pregnant women
7. Patients with psychogenic non-epileptic seizures (PNES)
8. Any other patients deemed unsuitable as study subjects by the principal investigator

Related Information

• Primary Sponsor: Marushima Aiki
• Source(s) of Monetary Support: University of Tsukuba Hospital