Efficacy and safety of perampanel oral loading in postanoxic super-refractory status epilepticus: A pilot study.
Simone Beretta, Giada Padovano, Andrea Stabile...
https://pubmed.ncbi.nlm.nih.gov/30159874/Actively Recruiting
Led by University of California, San Francisco · Updated on 2026-07-29
52
Participants Needed
1
Research Sites
21 weeks
Total Duration
Brain injury is a leading cause of death and disability for patients who survive cardiac arrest resuscitation, with seizures occurring in up to one-third of these patients. This trial is investigating the safety and feasibility of using perampanel to prevent post-cardiac arrest status epilepticus, a condition where seizures are difficult to control and often fatal. The study is a pilot randomized placebo-controlled trial focused on adults admitted to the intensive care unit after cardiac arrest. Participants will be randomly assigned to receive either perampanel or a placebo. Those in the perampanel group will receive an oral loading dose of 24 mg at randomization followed by 8 mg daily for four more days, totaling five days of treatment. The placebo group will receive a matching oral placebo load and daily doses over the same five-day period. The trial aims to evaluate safety by monitoring for severe adverse events during this treatment window. During the study, participants will be closely monitored in the intensive care unit with evaluations including seizure incidence, seizure frequency, time to seizure control, the number of anti-seizure medications needed, duration of anesthetic treatment for seizures, and time to awakening from coma. Safety and tolerability will be assessed over seven days, and neurological function will be evaluated at 180 days. The trials outcomes will help determine the feasibility of preventing seizures after cardiac arrest using perampanel.
CONDITIONS
PeRampanel fOr Status ePilEpticus pRophylaxis Post-cardiac Arrest
E
Edilberto Amorim, MD
K
Kevin Bao, BA
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University of California, San Francisco
Lead Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Perampanel | Placebo |
|---|---|---|
| What is it? | Perampanel is an anti-seizure drug that blocks AMPA glutamate receptors. In this trial, it is studied as a possible method to prevent status epilepticus in comatose adults following cardiac arrest. | A placebo is used as the inactive comparator in the trial. It does not contain any active anti-seizure medication and is given by the same method as perampanel. |
| Role in trial | Randomized intervention arm studied for its ability to prevent status epilepticus and seizures post-cardiac arrest. | Randomized control arm with inactive treatment, used to assess outcomes against perampanel. |
| Primary use | Investigated for prevention of status epilepticus and seizures in adults who remain comatose after out-of-hospital cardiac arrest. | Inactive comparator for evaluating the outcomes of seizure occurrence and status epilepticus in the same clinical scenario. |
| How is it given? | Administered as an add-on medication following cardiac arrest, under intensive care supervision. The exact route and dosage are defined by the protocol. | Given by the same method as perampanel to maintain blinding and identical procedures across groups. |
| Evidence status | Efficacy and safety for preventing status epilepticus after cardiac arrest are under investigation. A pilot study suggests perampanel may be used in super-refractory status epilepticus, but its preventive effect in this setting is yet to be established. | The placebo arm provides a control for evaluating outcomes with no active anti-seizure intervention. No prevention effect is expected. |
| Important limitations | The preventive use of perampanel for status epilepticus after cardiac arrest is not yet supported by established clinical evidence. Current evidence for perampanel in postanoxic status epilepticus is limited to small pilot studies, mostly for treatment rather than prevention, and broader data on safety in critically ill populations is limited. | As a control, the placebo arm does not provide active seizure prevention, and participants may remain at risk for post-cardiac arrest seizures or status epilepticus. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - 5 days
Participants receive either perampanel or placebo starting with an oral loading dose, followed by daily doses for four more days, to prevent seizures after cardiac arrest.
Daily assessments during treatment
Duration - 180 days
Participants are monitored for safety, seizure occurrence, and neurological function for up to 180 days after treatment.
Periodic neurological evaluations
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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Simone Beretta, Giada Padovano, Andrea Stabile...
https://pubmed.ncbi.nlm.nih.gov/30159874/Lawrence J Hirsch, Michael W K Fong, Markus Leitinger...
https://pubmed.ncbi.nlm.nih.gov/33475321/University of California, San Francisco
Lead Sponsor