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Prospective Open-label Evaluation of Cenobamate Adjunctive Treatment of Adults With Refractory Focal Epilepsy

10 augustus 2022 bijgewerkt door: Mid-Atlantic Epilepsy and Sleep Center, LLC

Prospective Open Label Evaluation of Cenobamate Adjunctive Treatment of Adults With Refractory Focal Epilepsy: a "Real-world Experience" Study.

To evaluate the efficacy, safety and tolerability of cenobamate as adjunctive treatment of refractory focal epilepsy

Studie Overzicht

Toestand

Werving

Conditie

Gedetailleerde beschrijving

The purpose of the study is to evaluate efficacy and safety of adjunctive cenobamate treatment of adults with drug-resistant focal epilepsy in "real world" clinical setting, providing "real world experience" to help guide future cenobamate treatment. This will be an open label study comparing seizure frequency during 52 weeks of baseline observation period with seizure frequency during 52 weeks of adjunctive cenobamate maintanance treatment. ~100 adults aged 18-70 with severe refractory focal epilepsy with focal seizures that have failed to respond to ≥ 4 antiseizure drugs (ASDs) +/- respective surgery +/- vagal nerve stimulator (VNS), responsive nerve stimulator (RNS) or deep brain stimulator (DBS) treatment with epilepsy duration of ≥ 2 years and followed by the Investigator and/or his epileptologist colleagues at the Investigator's institution for ≥ 1 year will be enrolled. Patients will be on ASDs deemed by the Investigator to have achieved the best seizure control to-date. No more than 5 ASDs will be used. VNS, RNS and DBS will be allowed and not counted as an ASD. However, patients on VNS, RNS or DBS will have to have had the device placed ≥ 6 months before study initiation and have had stable stimulator settings for ≥ 3 months. Baseline will include 52 weeks of prospectively kept, well documented seizure diaries that have been regularly, prospectively reviewed by the treating epileptologist during 52 weeks prior to study initiation. Retrospective review of these diaries will be allowed and count as baseline. As an alternative to seizure diaries, well-documented seizure frequency obtained during regular clinical visits, reviewed by the treating epileptologist and documented in the patient's chart during regular clinical visits during the 52 weeks' baseline period will be allowed in lieu of seizure diaries. ASDs will be held stable during the last month of baseline observation period. Following a baseline of 52 weeks patients will be started on cenobamate, administered orally in qhs, qd or b.i.d. schedule. Both starting dose and titration schedule up to initial target dose of 100-250 mg will follow FDA approved guidelines.

Cenobamate target dose will range from 100-400 mg/day. Within this range, the target dose will be individualized and will be the dose when seizure freedom, intolerable TEAEs or 400 mg/day is reached, whichever occurs first Maintenance period will start when seizure freedom, 250 mg/day dose or maximum tolerated dose of ≥ 100 mg/day is reached, whichever comes first. Maintenance treatment will last for 52 weeks. Total treatment period may vary between subjects depending on titration and final dose, but maintenance treatment period will be 52 weeks for all subjects. During both titration and cenobamate treatment, reduction of the dose of concomitant other ASDs will be allowed as clinically indicated; increase in the dose of concomitant ASDs will not be allowed, nor will initiation of any new antiseizure therapy other than cenobamate. Initiation of new antiseizure treatment or clinically indicated need for increase of ASD other than cenobamate will end of the active part of the study, although patients will be followed to the end of the 52 week maintenance treatment period.

Studietype

Observationeel

Inschrijving (Verwacht)

100

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Verenigde Staten
    • Maryland
      • Bethesda, Maryland, Verenigde Staten, 20817
        • Werving
        • Mid-Atlantic Epilepsy and Sleep Center
        • Hoofdonderzoeker:
          • Pavel Klein, MD
        • Contact:
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 70 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

NVT

Geslachten die in aanmerking komen voor studie

Allemaal

Bemonsteringsmethode

Kanssteekproef

Studie Bevolking

Male and female adults aged 18-70 with uncontrolled focal epilepsy

Beschrijving

Inclusion Criteria:

  1. Age 18-70
  2. Focal epilepsy uncontrolled in spite of past or present treatment with four or more anti-seizure drugs (ASDs), with focal aware motor seizures, focal unaware seizures and focal to bilateral tonic clonic seizures.
  3. Stable ASD doses for at least 30 days
  4. Epilepsy duration for ≥ 2 years
  5. Past/current treatment with ≥ 4 ASDs. VNS, RNS and DBS treatment will be allowed and will not count as an ASD. VNS, RNS and DBS setting must be stable for 3 months prior to enrollment.
  6. Seizure frequency of ≥1/month for ≥ 10/12 months before treatment initiation

Exclusion Criteria:

  1. Primary generalized epilepsy
  2. Focal aware non-motor seizures without bilateral tonic-clonic seizures
  3. Non-epileptic seizures
  4. Progressive neurological disease including neoplasm, CNS degenerative disorders including Alzheimer's disease
  5. Any systemic illness or unstable medical condition that might pose additional risk, including renal or liver disease, clinically uncontrolled cardiac disease other unstable metabolic or endocrine disturbances, and active systemic cancer
  6. Change in the dose of any ASD within 30 days prior to enrollment
  7. Active drug or alcohol dependence or any other factors that, in the opinion of the site investigators would interfere with adherence to study requirements
  8. Pregnancy
  9. Use of any CNS-active investigational drugs within 1 month of enrollment
  10. Resective epilepsy surgery less than 6 months before study initiation
  11. Vagal nerve stimulator VNS, RNS or DBS implantation less than 6 months before study initiation
  12. Adjustment of VNS, RNS or DBS settings less than 3 months before study initiation
  13. Inability or unwillingness of subject or legal guardian/representative to give written informed consent.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
The seizure frequency per 28 days.
Tijdsspanne: seizure count per 28 days, baseline 52 weeks, maintanance period 52 weeks
comparing seizure frequency per 28 day periods during maintanance treatment vs. baseline
seizure count per 28 days, baseline 52 weeks, maintanance period 52 weeks
seizure freedom rate
Tijdsspanne: 52 weeks of adjunctive cenobamate maintanance treatment
rate of seizure-free patients
52 weeks of adjunctive cenobamate maintanance treatment
>75% seizure frequency reduction
Tijdsspanne: seizure count per 28 days, baseline 52 weeks, maintanance period 52 weeks
rate of patients with >75% seizure frequency reduction, comparing seizure frequency per 28 day periods during maintanance treatment vs. baseline
seizure count per 28 days, baseline 52 weeks, maintanance period 52 weeks
treatment emergent adverse events rate
Tijdsspanne: 52 weeks of baseline period; whole treatment period
rate of treatment emergent adverse events
52 weeks of baseline period; whole treatment period
treatment discontinuation rate
Tijdsspanne: 52 weeks of baseline period; whole treatment period
rate of cenobamate treatment discontinuation
52 weeks of baseline period; whole treatment period

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
median seizure frequency reduction
Tijdsspanne: 52 weeks of baseline period; 52 weeks of adjunctive cenobamate maintanance treatment
median seizure frequency reduction evaluation in maintenance period
52 weeks of baseline period; 52 weeks of adjunctive cenobamate maintanance treatment
median seizure frequency reduction
Tijdsspanne: 52 weeks of baseline period; the whole treatment period
median seizure frequency reduction evaluation in treatment period
52 weeks of baseline period; the whole treatment period
seizure severity
Tijdsspanne: 52 weeks of baseline period; 52 weeks of adjunctive cenobamate maintanance treatment
evaluate a seizure severity composite score
52 weeks of baseline period; 52 weeks of adjunctive cenobamate maintanance treatment
quality of life change
Tijdsspanne: 52 weeks of baseline period; the whole treatment period
quality of life questionnaire (QOLIE-31-P) scores
52 weeks of baseline period; the whole treatment period
seizure-related injuries
Tijdsspanne: 52 weeks of baseline period; the whole treatment period
seizure-related injuries rate
52 weeks of baseline period; the whole treatment period
driving status
Tijdsspanne: 52 weeks of baseline period; the whole treatment period
rate of patients with changed driving status
52 weeks of baseline period; the whole treatment period

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Mid-Atlantic Epilepsy and Sleep Center, LLC

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

25 juni 2020

Primaire voltooiing (Verwacht)

25 juni 2023

Studie voltooiing (Verwacht)

30 november 2023

Studieregistratiedata

Eerst ingediend

31 december 2020

Eerst ingediend dat voldeed aan de QC-criteria

7 mei 2021

Eerst geplaatst (Werkelijk)

10 mei 2021

Updates van studierecords

Laatste update geplaatst (Werkelijk)

11 augustus 2022

Laatste update ingediend die voldeed aan QC-criteria

10 augustus 2022

Laatst geverifieerd

1 augustus 2022

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • maesc010

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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