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Recruiting NCT06262594

Lemborexant Treatment of Insomnia Linked to Epilepsy

Phase III Interventional Epilepsy Sleep

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Lemborexant, Placebo.
Who it may be relevant to
Registry conditions: Epilepsy, Sleep. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

The goal of this clinical trial is to assess whether Lemborexant can improve sleep in patients with epilepsy.

Interventions

  • Drug Lemborexant
    Drug is administered
  • Drug Placebo
    Drug is administered

Primary outcome measures

  • WASO [Time frame: 36 Days]

Eligibility criteria

Inclusion criteria

  • Sleep-related focal epilepsy
  • Contraception

Exclusion criteria

  • Changes in antiseizure medication 1 month before study protocol or during study protocol
  • Concomitant medications per SUNRISE1
  • Individuals with hepatic impairment
  • Female participants who are pregnant or breastfeeding
  • Individuals with compromised respiratory function
  • Individuals with a history of complex sleep-related behaviour
  • Individuals with rare hereditary diseases of galactose intolerance such as galactosemia or glucose-galactose malabsorption
  • Individuals with a history of dependence or tolerance - abuse, dependence, rebound insomnia
  • Individuals with psychiatric disorders with abnormal thinking and behavioural changes, depression, or suicidal ideation
  • Individuals with a diagnosis of narcolepsy

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Triple blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Duke University — Durham
Canada · 1 center
  • Health Sciences Centre — Winnipeg

Identifiers

NCT: NCT06262594 · L'ÉTOILE

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗