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Abstracts

Cenobomate Monotherapy: A Promising Approach to Epilepsy Treatment

Abstract number : 1.208
Submission category : 4. Clinical Epilepsy / 4C. Clinical Treatments
Year : 2023
Submission ID : 13
Source : www.aesnet.org
Presentation date : 12/2/2023 12:00:00 AM
Published date :

Authors :
First Author: Erkam Zengin, MD – Zucker School of Medicine at Hofstra/Northwell

Presenting Author: Ferhat Erol, MD – North Shore University Hospital

Andrea Guavera, MD – Zucker School of Medicine at Hofstra/Northwell; Phillip Yeung, MD – Zucker School of Medicine at Hofstra/Northwell; Kevin Pao, PharmD,AE-C, BCPS – Zucker School of Medicine at Hofstra/Northwell; Sean Hwang, MD – Zucker School of Medicine at Hofstra/Northwell; Fred Lado, MD – Zucker School of Medicine at Hofstra/Northwell

Rationale:

Cenobomate (CNB) is a novel anti-seizure medication approved as an adjunctive therapy for focal epilepsy by the Food and Drug Administration. While there is phase III RCT evidence on its effectiveness as an adjunctive therapy, evidence for monotherapy use remains limited. We conducted a retrospective chart review of patients receiving CNB monotherapy to examine efficacy and safety of CNB as monotherapy.



Methods:

We queried hospital pharmacy records for patients receiving CNB prescribed within our hospital network within a two year period. We then identified patients receiving CNB monotherapy. For the patients receiving CNB monotherapy, we conducted a chart review to determine the presence or absence of seizure freedom at last follow-up visit, the duration of seizure freedom, and the presence of adverse effects of CNB. Chart notes were reviewed to extract study data points.



Results:

From the database, we identified 342 patients receiving CNB.  37/342 (11%) were receiving CNB as monotherapy. The 28/37 patients who had observation periods exceeding six months were selected for further analysis. The median CNB maintenance dose after titration was 200mg (150 – 400 mg) and was accompanied by down-titration of other ASMs. The most frequent reasons for transitioning to CNB monotherapy were poor seizure control (75%), ASM intolerance (13%), or simplification of polytherapy (10%). In only one patient was CNB started as a monotherapy.     

Of the 14/28 patients who had an observation period exceeding 12 months, 8/14 were seizure free more than 12 months. 2/14 were seizure free 6-12 months. 1/14 was seizure free three months. 3/14 had a seizure < one month before last observation period.   

Of the 14/28 patients had observation period of 6-12 months, 10/14 were seizure free during the observation period, while 2/14 had a seizure one to six months, 2/14 had a seizure < one month before last observation period. Overall, 65% (18/28) of CNB monotherapy patients observed longer than six months were seizure free during the observation period.   

Prior to transition to monotherapy, 4% of the patients had taken three ASMs, 13% were taking two ASMs, and 50% were on monotherapy with a different ASM.  The ASMs most frequently prescribed were lacosamide (41%), levetiracetam (21%), oxcarbazepine (13%), divalproex or valproic acid (8%).    

16/28 (57%) of the patients reported side effects at various stages of treatment. The most prevalent side effects were fatigue (44%) and dizziness/ataxia (24%). Dizziness and ataxia often manifested initially as a cumulative dose-dependent side effect with concomitant use of other sodium channel blockers. Ataxia/dizziness side-effects resolved with down-titration and elimination of other ASMs. Other rarely reported side effects were mood changes, “brain fog,” cephalic sensation, and gastrointestinal intolerance 

 



Conclusions:

CNB is effective and well tolerated as monotherapy for seizure prevention.  CNB’s unique dual mechanism of action and demonstrated effectiveness offer a potential alternative for patients who have not achieved seizure control with other medications. Our findings indicate that CNB monotherapy may simplify treatment regimens and reduce the need for polytherapy



Funding: None

Clinical Epilepsy