Lemborexant for Epilepsy
(L'ÉTOILE Trial)
Recruiting at 1 trial location
MC
MC
Overseen ByMarcus C Ng, MD, FRCPC
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: University of Manitoba
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 4 JurisdictionsThis treatment is already approved in other countries
Trial Summary
What is the purpose of this trial?
The goal of this clinical trial is to assess whether Lemborexant can improve sleep in patients with epilepsy.
Will I have to stop taking my current medications?
The trial does not specify if you must stop taking your current medications, but you cannot change your antiseizure medication for at least one month before and during the study. Also, certain other medications might not be allowed, as per the SUNRISE1 guidelines.
Eligibility Criteria
This clinical trial is for individuals who have sleep-related focal epilepsy and are willing to use contraception. It's not specified, but typically participants would need to be in good general health aside from their epilepsy and insomnia.Inclusion Criteria
I have epilepsy that occurs during sleep.
I am using birth control.
Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive Lemborexant or placebo to assess improvement in sleep for patients with epilepsy
5 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Treatment Details
Interventions
- Lemborexant
Trial OverviewThe trial is testing Lemborexant, a potential treatment for insomnia in people with epilepsy. Participants will either receive Lemborexant or a placebo (a pill without any active drug) to see if there's an improvement in sleep.
Participant Groups
2Treatment groups
Active Control
Placebo Group
Group I: Investigational Product FirstActive Control2 Interventions
10mg qhs
Group II: Placebo FirstPlacebo Group2 Interventions
0mg
Lemborexant is already approved in United States, Canada, Japan for the following indications:
Approved in United States as Dayvigo for:
- Insomnia characterized by difficulties with sleep onset and/or sleep maintenance in adults
Approved in Canada as Dayvigo for:
- Insomnia characterized by difficulties with sleep onset and/or sleep maintenance, with or without associated impairment in daily functioning
Approved in Japan as Dayvigo for:
- Treatment of insomnia
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Manitoba
Lead Sponsor
Trials
628
Recruited
209,000+
Duke University
Collaborator
Trials
2,495
Recruited
5,912,000+
Findings from Research
Felbamate (FBM) significantly reduced the total number of seizures by 26% in patients with therapy refractory Lennox-Gastaut syndrome, compared to a 5% increase in the placebo group, indicating its efficacy as an antiepileptic drug.
Approximately 50% of patients taking FBM experienced at least a 50% reduction in seizure frequency, and the drug was generally well tolerated, with mild side effects like gastrointestinal symptoms and somnolence.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Felbamate in the treatment of Lennox-Gastaut syndrome.Jensen, PK.[2019]
In a retrospective case series of six dogs with idiopathic/genetic epilepsy, adding oral felbamate resulted in an impressive 82% reduction in seizure frequency over a short-term period, with 83% of dogs showing a significant response.
Long-term follow-up (averaging 13 months) indicated that 67% of the dogs remained responders, achieving an average seizure reduction of 98%, and some dogs maintained seizure-free status, suggesting that felbamate could be a promising add-on treatment for resistant cases of canine epilepsy.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Felbamate as an oral add-on therapy in six dogs with presumptive idiopathic epilepsy and generalized seizures resistant to drug therapy.Dewey, CW., Rishniw, M., Sakovitch, K.[2022]
In a study of 73 patients with Lennox-Gastaut syndrome, felbamate treatment resulted in a 34% reduction in atonic seizures and a 19% decrease in total seizure frequency, compared to a placebo group that experienced a 9% decrease and a 4% increase, respectively.
Felbamate was associated with improved quality of life evaluations from parents or guardians, and while it did not significantly reduce seizures during video monitoring, it did lead to a notable decrease in tonic-clonic seizures, indicating its potential efficacy in managing this complex condition.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Efficacy of felbamate in childhood epileptic encephalopathy (Lennox-Gastaut syndrome).[2018]
References
Felbamate in the treatment of Lennox-Gastaut syndrome. [2019]
Felbamate as an oral add-on therapy in six dogs with presumptive idiopathic epilepsy and generalized seizures resistant to drug therapy. [2022]
Efficacy of felbamate in childhood epileptic encephalopathy (Lennox-Gastaut syndrome). [2018]
Felbamate. [2019]
Felbamate overdose: a case report and discussion of a new antiepileptic drug. [2019]
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